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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/10/14-9/10/14

Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm (Forrest Labs)

Meeting Date: 9/9/14-9/9/14

Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/27/14-3/27/14

Meeting Details:

The committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 2/12/14-2/12/14

Meeting Details:

The committee will discuss new drug application (NDA) 204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent. The applicant is also proposing that cangrelor be indicated to maintain P2Y12 inhibition in patients with acute coronary syndromes or patients with stents who are at increased risk for thrombotic events (such as stent thrombosis) when oral P2Y12 therapy is interrupted due to surgery. P2Y12 is a protein involved in blood clotting; inhibiting this protein is a key mechanism of action of cangrelor.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs AdComm

Meeting Date: 1/14/14-1/16/14

Meeting Details:

*** DAY 1 *** - The committee will discuss new drug application (NDA) 203202, NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. *** DAY 2 *** - The committee will discuss new drug application (NDA) 204886, vorapaxar sulfate, proposed trade name ZONTIVITY, 2.5 milligram tablets, submitted by Merck Sharp & Dohme Corp., Inc., for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI). The applicant also proposes that ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. *** DAY 3 *** - The committee will discuss supplemental new drug application (sNDA) 202439/S-002, rivaroxaban, trade name XARELTO 2.5 milligram tablets, submitted by Janssen Pharmaceuticals, Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after suffering acute coronary syndrome [ST elevation myocardial infarction, non-ST elevation myocardial infarction, or unstable angina].

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 8/6/13-8/6/13

Meeting Details:

On August 6, 2013, the committee will discuss new drug application (NDA) 204819, proposed trade name ADEMPAS (riociguat coated tablet), submitted by Bayer HealthCare Pharmaceuticals Inc., for the treatment of: (1) chronic thromboembolic pulmonary hypertension World Health Organization (WHO) Group 4 to improve exercise capacity and WHO functional class and (2) pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 8/5/13-8/5/13

Meeting Details:

On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: Cardiovascular and Renal Drugs Advisory Committee

Meeting Date: 9/14/12-9/14/12

Meeting Details:

The committee will discuss new drug application (NDA) 203446, imatinib mesylate, submitted by Novartis Pharmaceuticals Corp., as adjunctive therapy for the treatment of pulmonary arterial hypertension (WHO Diagnostic Group 1), to improve exercise capacity and cardiopulmonary hemodynamics in patients who remain symptomatic despite treatment with two or more approved vasodilator therapies ("vasodilator therapies" refer to medicines used to dilate blood vessels and thereby reduce resistance to blood flow).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 9/13/12-9/13/12

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 203009, lixivaptan, submitted by Cardiokine Biopharma, LLC, for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively.

 

       
Location: White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 5/23/12-5/23/12

Meeting Details:

On May 23, 2012, the Committee will discuss supplemental new drug application (sNDA) 202439/S-002 XARELTO (rivaroxaban), submitted by Janssen Pharmaceuticals, Inc. to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) [ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting Options**Meeting Cancelled: Cardio & Renal Drugs Adcomm**

Meeting Date: 3/27/12-3/27/12

Meeting Details:

On March 27, 2012, the committee will begin with a closed session from 8 a.m. to 10:45 a.m. Following the closed session, from 11 a.m. to 5 p.m., the meeting will be open to the public. The committee will discuss biologics license application 125410, proposed tradename REPLAGAL (agalsidase alfa), submitted by Shire Human Genetics Therapies, for an enzyme replacement therapy for patients with Fabry disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 2/23/12-2/23/12

Meeting Details:

The committee will discuss new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non- Diabetic Autonomic Neuropathy.

 

       
Location: Hilton Washington DC/ Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJNJ(Rivaroxaban Tablets) - Cardiovascular and Renal Drugs AdComm

Meeting Date: 9/8/11-9/8/11

Meeting Details:

On September 8, 2011, the committee will discuss new drug application (NDA) 202439, rivaroxaban tablets, submitted by Johnson & Johnson Pharmaceutical Research and Development, L.L.C., on behalf of Ortho-McNeil-Janssen-Pharmaceuticals, for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on

 

       
Location: UMUC Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs AdComm

Meeting Date: 5/2/11-5/2/11

Meeting Details:

On May 2, 2011, the committees will discuss safety considerations of ultrasound contrast agents (materials intended to improve the clarity of ultrasound imaging), particularly related to new information and developments since the prior Advisory Committee meeting on the same topic on June 24, 2008. The discussion will include the results of required postmarketing safety studies and data from postmarketing surveillance. Specific drugs to be discussed include: (1) New drug application (NDA) 21-064, perflutren lipid microsphere injectable suspension, Lantheus Medical Imaging, Inc.; (2) NDA 20-899, perflutren protein-type A microspheres injectable suspension, GE Healthcare; and (3) the investigational new drug (IND) application for sulfur hexafluoride microbubble injection, Bracco Diagnostics, Inc. Perflutren lipid microsphere injectable suspension and perflutren protein-type A microspheres injectable suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border (improve the clarity of imaging of specific areas of the left lower side of the heart).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/8/10-12/8/10

Meeting Details:

On December 8, 2010, from 8 a.m. to 11:30 a.m., the committee will discuss and provide general advice on the appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events (such as heart attacks) in patients with aspirin intolerance due to immunologically-based adverse reactions (adverse events related to immune system function), specifically in the setting of coronary artery bypass grafting (also referred to as "heart bypass surgery").

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs AdComm

Meeting Date: 10/18/10-10/18/10

Meeting Details:

The committee will consider the results and analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP (darbepoetin alfa), manufactured by Amgen, Inc. This meeting is a follow-up to the September 2007 advisory committee meeting at which the committee discussed updated information on the risks and benefits of erythropoeisis-stimulating agents (drugs that stimulate production of red blood cells), marketed under the brand names ARANESP, EPOGEN, and PROCRIT, manufactured by Amgen, Inc., when used in the treatment of anemia (low red blood cell counts) due to chronic kidney failure.

 

       
Location: UMUC Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/20/10-9/20/10

Meeting Details:

The committee will discuss new drug application (NDA) 22512, dabigatran etexilate mesylate capsules, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of prevention of stroke in patients with atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs AdComm

Meeting Date: 7/29/10-7/29/10

Meeting Details:

On July 29, 2010, the committee will discuss Revatio (sildenafil) for the treatment of pediatric pulmonary arterial hypertension (PAH) and whether to amend the clinical trials section of the written request, issued by FDA to Pfizer, to include assessment of a hemodynamic endpoint. An area of particular interest will be what the appropriate study endpoint should be in patients with PAH unable to perform exercise testing. The discussion will help the agency determine what studies to request for products intended to treat pediatric PAH.

 

       
Location: Marriott Inn Adelphi, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs AdComm

Meeting Date: 7/28/10-7/28/10

Meeting Details:

On July 28, 2010, the committee will discuss new drug application (NDA) 22433, ticagrelor tablets, 90 milligrams, manufactured by AstraZeneca LP, for the proposed indication for use in acute coronary syndrome (including heart attacks and any of a group of signs and symptoms, such as chest pain or shortness of breath, that are consistent with blockages in the blood vessels that supply the heart).

 

       
Location: The Marriott Inn and Conference Center Adelphi, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/1/10-3/1/10

Meeting Details:

On March 1, 2010, the committee will discuss biologics license application (BLA) 125288, for belatacept injectable, by Bristol Myers Squibb, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney.

 

       
Location: Hilton Silver Spring, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 1/11/10-1/11/10

Meeting Details:

On January 11, 2010, the committee will discuss supplemental drug application (sNDA) 21-742, nebivolol tablets, Forest Laboratories, Inc., for the proposed indication (use) of treatment of chronic heart failure.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/7/09-12/8/09

Meeting Details:

On December 7, 2009, the committee will discuss new drug application (NDA) 21-560, for everolimus oral tablets, by Novartis Pharmaceuticals Corporation, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney. On December 8, 2009, the committee will discuss safety considerations related to FDA-approved gadolinium-based contrast agents used with magnetic resonance imaging (MRI) scans. An MRI is a medical imaging technique that does not require x-rays. These scans outline the internal body structures such as organs and other soft tissues. Contrast agents are substances injected into the body before MRI scans, helping doctors to better see and interpret MRI findings. FDA approved gadolinium-based contrast agents include: gadobenate dimeglumine (MULTIHANCE), gadodiamide (OMNISCAN), gadopentetate dimeglumine (MAGNEVIST), gadoteridol (PROHANCE), gadoversetamide (OPTIMARK), gadoxetate disodium (EOVIST), and gadofosveset (ABLAVAR, previously known as VASOVIST).

 

       
Location: Hilton Washington DC North/Gaithersburg Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 7/28/09-7/29/09

Meeting Details:

The committee will discuss new drug application (NDA) 22449, binodenoson injectable, lypholized solid 250 micrograms vial, King Pharmaceuticals Research and Development, Inc., for the proposed indication: Short acting coronary vasodilator for use as an adjunct to noninvasive myocardial perfusion imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease. The committee will discuss supplemental new drug application (sNDA) 20850/S025, telmisartan tablets, 80 milligrams, Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of reduction in the risk of myocardial infarction, stroke, death from cardiovascular causes, or hospitalization for congestive heart failure in patients 55 years or older who are at high risk of developing major cardiovascular events.

 

       
Location: Hilton Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/18/09-3/19/09

Meeting Details:

The committee will discuss new drug application (NDA) 22-425, dronedarone 400 milligrams oral tablets, Sanofi Aventis, for the proposed indication in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death. The committee will discuss new drug application (NDA) 22406, rivaroxaban oral tablets (10 milligrams) Johnson & Johnson Pharmaceutical Research & Development, L.L.C., for the proposed indication for use in prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery.

 

       
Location: Marriott, Adelphi MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 2/3/09-2/3/09

Meeting Details:

The committee will discuss new drug application (NDA) 22-307, prasugrel hydrochloride film coated oral tablets, 5 milligrams (mg) and 10 mg, Eli Lilly and Company, for the proposed indication for use in acute coronary syndrome.

 

       
Location: Hilton Silver Spring, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/10/08-12/10/08

Meeting Details:

The committee will discuss new drug application (NDA) 22-349, IMAGIFY (perflubutane polymer microspheres) injectable suspension, Acusphere Inc., proposed for use as an ultrasound imaging agent indicated for patients with stable chest pain being evaluated for inducible ischemia for the detection of coronary artery disease based on assessment of myocardial perfusion and wall motion.

 

       
Location: Hilton SS MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 6/25/08-6/25/08

Meeting Details:

The committee will discuss new drug application [NDA) 22-275, tolvaptan (proposed trade name SAMSKA), Otsuka Pharmaceutical Development & Commercialization, Inc., for the proposed indication of treatment of hypervolemic and euvolemic, hyponatremia. The committee will hear presentations from FDA and the sponsors specifically regarding change in sodium level as basis for drug approval.

 

       
Location: Hilton Washington DC/Silver Spring Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 6/24/08-6/24/08

Meeting Details:

The committee will discuss safety considerations in the development of ultrasound contrast agents, based upon the experience with the following: (1)New drug application (NDA) 21-064, perflutren lipid microsphere injectable suspension, Lantheus Medical Imaging, Inc.; (2) NDA 20-899, perflutren protein-type A microspheres injectable suspension, GE Healthcare; and (3) the investigational new drug application for sulphur hexafluoride microbubble injection, Bracco Diagnostics. Perflutren lipid microsphere injectable suspension and perflutren protein-type A microspheres injectable suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardia1 borders.

 

       
Location: Hilton Maryland Ballroom Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/11/07-12/12/07

Meeting Details:

On December 11, 2007, the committee will discuss new drug application (NDA) 22-034, vernakalant hydrochloride injection, 20 milligrams (mg) per milliliter (ml), Astellas Pharma U.S., Inc., for the proposed indication of use for conversion of atrial fibrillation to normal sinus rhythm. On December 12, 2007, the committee will discuss NDA 22-123, PULZIUM (tedisamil sesquifumarate) IV solution 2 mg per ml, Solvay Pharmaceuticals, Inc., for the proposed indication of use for conversion of atrial fibrillation or atrial flutter to normal sinus rhythm.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/16/07-10/16/07

Meeting Details:

On October 16, 2007 the committee will discuss regulatory considerations for extending the use of phosphate binders from the dialysis population (where they are approved) to the pre-dialysis population (where no products are approved). The committee will hear presentations on the topic from Shire Development, Genzyme Corp, and Fresenius Medical Care. On October 17, 2007 the committee will discuss data requirements and study designs appropriate to characterize the durability of treatment effect of REVATIO (sildenafil citrate) Pfizer Inc in the pulmonary arterial hypertension in children.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Cardio and DSRM AdComm

Meeting Date: 9/12/07-9/12/07

Meeting Details:

The committee will discuss clinical data for aprotinin injection (TRASYLOL, Bayer Pharmaceuticals), a product indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at increased risk for blood loss and blood transfusion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Cardio and DSRM - Amgen

Meeting Date: 9/11/07-9/11/07

Meeting Details:

The committee will discuss updated information on the risks and benefits of erythropoeisis-stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.) when used in the treatment of anemia due to chronic renal failure.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 4/18/07-4/18/07

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 20-758/S-037, AVALIDE (irbesartan plus hydrochlorothiazide), Bristol-Myers Squibb Co. The sponsor is seeking approval for first-line use in hypertensive patients unlikely to achieve blood pressure goals on one drug. The committee will be asked to consider what constitutes adequate data to support such a claim and how the information can be most usefully displayed in labeling.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/21/06-9/21/06

Meeting Details:

The committee will discuss clinical data for aprotinin injection (trade name, TRASYOL), an approval product, new drug application (NDA) 020-304, Bayer Pharmaceuticals with the indication for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 4/25/06-4/26/06

Meeting Details:

On April 25, 2006, the committee will meet between 8 a.m. to 5 p.m., to discuss new drug application (NDA) 21-359 CELLEGESIC (nitroglycerin [NTG] ointment), 0.4% intra-anal, Cellegy Pharmaceuticals, Inc., for the proposed indication of relief of pain associated with anal fissures. On April 26, 2006, the committee will meet between 8 a.m. to 12 noon, to discuss the agency's draft recommendations for relabeling of antihypertensive drugs for outcome claims, as a followup to the committee's meeting on June 15, 2005, where the committee discussed class labeling of antihypertensive drugs based on the proximity of their data to outcome trials. Following this, from approximately 1 p.m. to 5 p.m., the committee will discuss the "Placebo in Hypertension Adverse Reaction Meta-Analysis" Study, a meta-analysis of more than 80,000 patients in placebo-controlled trials of antihypertensive medications, which evaluated the risk of irreversible harm in conducting placebo-controlled trials in patients with hypertension.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 11/16/05-11/16/05

Meeting Details:

The committee will discuss new drug application (NDA) 21-628, proposed trade name CERTICAN (everolimus) Tablets (0.25 milligrams (mg), 0.50 mg, 0.75 mg, and 1.0 mg), Novartis Pharmaceuticals Corporation, for the proposed indication of prophylaxis of rejection in heart transplantation.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 6/15/05-6/16/05

Meeting Details:

On June 15, 2005, the committee will discuss class labeling of antihypertensive drugs based on the proximity of their data to outcome trials. On June 16, 2005, the committee will discuss new drug application (NDA) 20-727, proposed trade name BIDIL (hydralazine hydrochloride/isosorbide dinitrate) Tablets, (37.5 milligrams (mg) hydralazine hydrochloride/20 mg isosorbide dinitrate), NitroMed, Inc., proposed for the indication of heart failure, based on the results from the African American Heart Failure Trial.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardio and Renal Drugs Advisory Committee

Meeting Date: 4/5/05-4/5/05

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) S-036 to approved new drug application (NDA) 19-787, NORVASC (amlodipine besylate) Tablets (2.5 milligrams (mg), 5 mg, and 10 mg), Pfizer Inc., proposing a change in labeling for the two additional indications of: (1) reducing the risk of fatal coronary heart disease and nonfatal myocardial infarction, and (2) reducing the risk of stroke, based on the effectiveness demonstrated in the antihypertensive and lipid lowering treatment to prevent heart attack trial (ALLHAT).

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 2/24/05-2/24/05

Meeting Details:

The committee will discuss supplemental new drug applications (sNDAs) S-022, S-024, and S-025 to approved new drug application (NDA) 20-838, ATACAND (candesartan cilexetil) Tablets (4 milligrams (mg), 8 mg, 16 mg, and 32 mg), AstraZeneca LP, for the use in the treatment of patients with congestive heart failure, specifically in the following ways: (1) S-022 reducing the risk of cardiovascular mortality or heart failure hospitalization when added to an angiotensin-converting enzyme inhibitor-containing regimen in congestive heart failure patients with left ventricular systolic dysfunction; (2) S-024, reducing the risk of cardiovascular mortality or heart failure hospitalization in congestive heart failure patients with left ventricular systolic dysfunction, as a primary renin-angiotensin-aldosterone system modulating treatment; and (3) S-025, reducing the frequency of hospitalizations for heart failure in congestive heart failure patients with preserved left ventricular systolic dysfunction. ATACAND is currently approved for use in the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs Advisory

Meeting Date: 9/10/04-9/10/04

Meeting Details:

On September 10th, th Cardiovascular & Renal Drugs Advisory Committee will meet to discuss AstraZeneca’s Exanta ORAL DIRECT THROMBIN INHIBITOR FOR THE PREVENTION AND TREATMENT OF VENOUS THROMBOEMBOLISM for prevention of stroke in patients with atrial fibrillation.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 12/8/03-12/9/03

Meeting Details:

On December 8, 2003, the committee will discuss whether aspirin should be recommended for primary prevention of myocardial infarction. On December 9, 2003, the commmittee will review Ranexa(TM) (ranolazine) for the treatment of chronic angina.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal AdComm

Meeting Date: 5/29/03-5/30/03

Meeting Details:

On May 29, the committee will discuss QT prolongation issues with two new drug application Sanofi-Synthelabo’s hypeplasia agent UroXatral and Bayer's Levitra for treatment of erectile disfunction. The committee will discuss: (1.) Clinical trial designs for assessment of QT prolongation. (2.) Approaches to the correction of QT internvals which affect heart rate and (3.) Risk of cardiact arythmya. On May 30, the committee will be closed to the public.

 

       
Location: HOL - SS Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 1/6/03-1/7/03

Meeting Details:

On January 6, 2003, beginning at 8:30 a.m., the committee will discuss supplemental new drug application (SNDA) 20-386/S-032, COZAAR (losartan potassium) Tablets, Merck and Co., for the proposed indication of reduction in the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy. On January 7, 2003, beginning at 8 a.m., the committee will discuss SNDA 20-297/S-009, COREG (carvedilol), GlaxoSmithKline, for the proposed indication to reduce mortality and the risk of infarction in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction <=40 percent.

 

       
Location: Holiday Inn Silver Spring, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular AdComm

Meeting Date: 7/18/02-7/19/02

Meeting Details:

On July 18th, beginning at 8:00 a.m., the Committee will discuss supplemental new drug application 20-838/S-015, ATACAND (candesartan cilexetil) Tablets, AstraZeneca LP, for a proposed claim of comparative efficacy of candesartan cilexetil and losartan in hypertension. Beginning at 1 p.m., the committee will discuss new drug application, 21-387, Pravigard, PAC (pravastatin sodiumaspirin co-packaged product), Bristol-Myers Squibb Company, proposed for long-term management to reduce the risk of cardiovascular events (death, nonfatal myocardial infarction, myocardial revascularization procedures, and ischemic stroke) in patients with clinically evident coronary heart disease. On July 19, 2002, beginning at 8:00 a.m., the committee will discuss NDA 21-188, Vanlev (omapatrilat) Bristol-Myers Squibb Company, proposed for the treatment of hypertension.

 

       
Location: Holiday Inn Bethesda, Maryland Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs Advisory

Meeting Date: 4/12/02-4/12/02

Meeting Details:

The Committee will discuss Merck’s Cozaar (losartan) first of a new class of antihypertensive therapy drugs for the treatment of type 2 diabetic patients with nephropathy.

 

       
Location: Holiday Inn, Silver Spring. MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs Advisory Committee

Meeting Date: 1/17/02-1/18/02

Meeting Details:

On January 17, 2002, the committee will discuss new drug application (NDA) 20-757/S-021, AVAPRO (irbesartan), Sanofi-Synthelabo (c/o Bristol-Myers Squibb), for the treatment of hypertensive patients with type 2 diabetic renal disease. On January 18, 2002, the committee will discuss NDA 21-387, pravastatin/aspirin, Bristol-Myers Squibb, co- package, for long-term management to reduce the risk of death, nonfatal myocardial infarction, myocardial revascularization procedures, and ischemic stroke in patients with clinically evident coronary heart disease.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory

Meeting Date: 10/11/01-10/11/01

Meeting Details:

The committee will discuss new drug applications (NDA) 20-665(capsules) and NDA 21-283 (tablets) Diovan (valsartan), Novartis Pharmaceuticals Corp., for the treatment of patients with heart failure.

 

       
Location: Masur Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 8/9/01-8/10/01

Meeting Details:

On August 9, 2001, in the morning, the committee will discuss new drug application (NDA) 21-272, Remodulin (treprostinil sodium injection), United Therapeutics Corp., for the treatment of pulmonary hypertension. On August 9, 2001, in the afternoon, the committee will discuss NDA 21-321, Extraneal (7.5 percent icodextrin) peritoneal dialysis solution, Baxter Healthcare Corp. On August 10, 2001, in the morning, the committee will discuss NDA 21-290, Tracleer (bosentan tablets), Actelion, Ltd., for the treatment of pulmonary hypertension.

 

       
Location: National Institutes of Health Rockville Pike, Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs

Meeting Date: 5/24/01-5/25/01

Meeting Details:

On May 24, 2001, the committee will discuss: (1) Published interim analyses of ALLHAT (antihypertensive and lipid lowering treatment to prevent heart attack trial) sponsored by the National Heart, Lung, and Blood Institute, NIH, and (2) response to the citizen's petition of Lawrence D. Bernhardt and Arnold Liebman, regarding new drug application (NDA) 19-668, Cardura (doxazosin), Pfizer, Inc. On May 25, 2001, the committee will discuss NDA 20-920 Natrecor (nesiritide), Scios, Inc., for treatment of acute heart failure.

 

       
Location: Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 10/20/00-10/20/00

Meeting Details:

On October 19, 2000, the committee will meet in closed session. On October 20, 2000, the committee will discuss dose response using data from approved antihypertensive drugs.

 

       
Location: Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 5/1/00-5/2/00

Meeting Details:

On May 1 the committee will discuss new drug applications (NDA) 21-188, Vanlev (omapatrilat) Bristol Myers Squibb to be indicated for hypertension, Altace (ramipril) Capsules, King Pharmaceuticals, Inc.. for significant reduction of mortality, myocardial infarction, stroke, revascularization procedures, and heart failure in high risk patients. On May 2, the committee will discuss Refludan [lepirudin(-DNA) for injection] Aventis Pharmaceuticals, Inc., for anticoagulation in adult patients with acute coronary syndromes (unstable angina and acute myocardial infarction without ST segment elevations on electrocardiogram (EKG).

 

       
Location: Bethesda, MD. Related News Links: Not Available
Time: 8:30AM-5:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 10/14/99-10/15/99

Meeting Details:

On October 14, 1999, the committee will discuss acutecoronary syndromes. On Oct. 15, the committee will discuss Simdax, for the treatment of patients with decompensated heart failure, in conjunction with conventional therapy.

 

       
Location: NIH Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 4/29/99-4/30/99

Meeting Details:

On April 29, 1999, the committee will discuss new drug application (NDA) 19-865/S-007, Betapace® (sotolol), Berlex Laboratories Inc., for prevention of recurrence of chronic or paroxysmal symptomatic atrial fibrillation/atrial flutter; on April 30, 1999, the committee will discuss the interpretation of anti-arrhythmic trials in patients with implanted ventricular defibrillators.

 

       
Location: National Institutes of Health Clinical Center Ja Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 1/29/99-1/29/99

Meeting Details:

On January 28, 1999, the committee will discuss new drug application (NDA) 20-931, Tikosyn Capsules (dofetilide), Pfizer Pharmaceuticals Production Corp., Ltd., for maintenance of normal sinus rhythm with associated symptomatic relief in patients with supraventricular arrhythmias, e.g., atrial flutter, atrial fibrillation, and paroxsysmal supraventricular tachycardia; and conversion of atrial fibrillation and flutter to normal sinus rhythm. On January 29, 1999, the committee will discuss NDA 20-920, Natrecor Injection(nesiritide), Scios, Inc., for short term treatment of congestive heart failure.

 

       
Location: Natcher Conference Center - NIH Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 10/22/98-10/23/98

Meeting Details:

On October 22, 1998, the committee will discuss guidelines for the study of congestive heart failure. On October 23, 1998, the committee will discuss new drug application (NDA)20-873, Hirulog (bivalirudin, The Medicines Company), injection for anticoagulation in patients undergoing percutaneous transluminal angioplasty (PCTA).

 

       
Location: Jack Masur Auditorium Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 7/9/98-7/9/98

Meeting Details:

On July 9, 1998, the committee will review new drug application (NDA)20-863 Pletal® (cilostazol), Otsuka America Pharmaceutical Inc.) to be indicated for intermittent claudication.

 

       
Location: NIH, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 4/9/98-4/10/98

Meeting Details:

April 9, 1998 ARDS - Pathophysiology/Current Therapies - Clinical Trials Neonatal Respiratory Failure - Pathophysiology - Current Therapies - Clinical Trials April 10, 1998 NDA's 20-912 and 20-913, Aggrastat (tirofiban hydrochloride intravenous injection, Merck Research Laboratories), indicated, in combination with heparin, to prevent cardiac ischemic events in patients with unstable angina or non-Q-wave myocardial infraction, including those patients in whom coronary angiography and angioplasty/atherectomy are clinically indicated.

 

       
Location: Jack Masur Auditorium, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 10/23/97-10/24/97

Meeting Details:

On October 23, 1997, the committee will discuss basic statistical considerations for the evaluation of active control clinical trials, and new drug application (NDA) 20-845, inhaled nitric oxide (Ohmeda Pharmaceutical Products Division, Inc.), for treatment of primary pulmonary hypertension of the newborn. On October 24, 1997, the committee will discuss NDA 20-839, PlavixTM (clopidogrel bisulfate, Sanofi Pharmaceuticals, Inc.), for prevention of vascular ischemic events in patients with a history of symptomatic atherosclerotic disease.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 6/26/97-6/26/97

Meeting Details:

On June 26, 1997, the committee will discuss new drug application (NDA) 19-922, CorlopamTM (fenoldopam mesylate, Neurex), for the short-term treatment of hypertension when oral therapy is not feasible or possible and for use in hypertensive crisis; NDA 20-164, Lovenox Injection (enoxaparin sodium, Rhone-Poulenc Rorer), to be indicated for the treatment of unstable angina and non-Q-wave myocardial infarction, concurrently administered with aspirin.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 2/27/97-2/27/97

Meeting Details:

On February 27, 1997, the committee will discuss: (1) NDA 20-727, BiDil (hydralazine HCl/isosorbide dinitrate tablets, Medco Research, Inc., to be indicated for treatment of chronic congestive heart failure as an adjunct to standard therapy in patients intolerant to or having contraindications to angiotensin converting enzyme (ACE) inhibitor therapy; and (2) NDA 20-297, Coreg TM (carvedilol, SmithKline Beecham), to be indicated for the treatment of moderate, chronic congestive heart failure. On February 28, 1997, the committee will discuss: (1) NDA 20-689, Posicor TM (mibefradil, Hoffmann La Roche), to be indicated for hypertension and angina; and (2) NDA 20-718, Integrilin (intrifiban, COR Therapeutics, Inc.), to be indicated as adjunct therapy to aspirin and heparin in patients undergoing percutaneous transluminal coronary angioplasty for prevention of acute cardiac ischemic complications related to abrupt closure of treated coronary vessels.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Nonprescription and Cardiovascular and Renal Drugs Advisory Committee

Meeting Date: 1/22/97-1/22/97

Meeting Details:

The committees will jointly discuss issues relevant to professional labeling indications for aspirin. A citizen petition requested that the Commissioner of Food and Drugs approve various vascular professional labeling indications for aspirin. FDA has already acted on some of the issues raised, while others have not been resolved. FDA is now soliciting advice and opinions from the advisory committees regarding the use of aspirin for expanded professional labeling indications for aspirin. Issues to be discussed include the use of aspirin in patients deemed to be at elevated risk of cardiovascular events due to some form of vascular disease or other conditions implying an increased risk of occlusive vascular disease (i.e., patients undergoing coronary, cerebral, or peripheral arterial revascularization procedures; patients with chronic nonvalvular atrial fibrillation; patients requiring hemodialysis access with a fistula or shunt; patients with chronic stable angina; and other patients deemed to be at elevated risk). The agency encourages investigators, academicians, and members of the pharmaceutical industry with information about the use of aspirin in patients at increased risk of cardiovascular events to respond to this notice.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 5/2/96-5/3/96

Meeting Details:

On May 2, 1996, the committee will discuss: (1) New drug application (NDA) 20-297, Supplement 1, Coreg (carvedilol), SmithKline Beecham, to be indicated for use in congestive heart failure; and (2) NDA 20-405, Lanoxin (digoxin)tablets, Glaxo-Wellcome, for congestive heart failure, and control of ventricular rate in atrial fibrillation. On May 3, 1996, the committee will discuss product license application 95-1167, reteplase, Boehringer Mannheim, for management of acute myocardial infarction (AMI) in adults, lysis of thrombi obstructing coronary arteries, improvement of ventricular function following AMI, reduction of the incidence of congestive heart failure, and reduction of mortality associated with AMI.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 1/25/96-1/26/96

Meeting Details:

On January 25, 1996, the committee will discuss a Current Controversy: Calcium Channel Blockers. On January 26, 1996, the committee will review the Center for Biologics Evaluation and Research's product license application 95-1210, imciromaba pentetate (Myoscint, Centocor), a monoclonal antibody for use as an imaging agent for diagnosis of cardiac necrosis.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 10/19/95-10/20/95

Meeting Details:

On October 19, 1995, the committee will discuss NDA: 20-491, ibutilide (Convert, The Upjohn Co.), for conversion of atrial flutter and atrial fibrillation, and NDA 20-546, vasoprost (Alprostadil Schwarz-Pharma Kremers Urban) for severe peripheral arterial occlusive disease to reduce the incidence of leg amputations in nondiabetic patients. On October 20, 1995, the committee will discuss ``Anti-hypertensive Agents; Guidelines for Therapy.''

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 8/28/95-8/28/95

Meeting Details:

The committee will discuss development of a clinical program for study of nitric oxide in the treatment of primary pulmonary hypertension in newborns.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 2/23/95-2/24/95

Meeting Details:

On February 23, 1995, the committee will discuss: (1) NDA 09-218, S-76, Dupont Merck, Coumadin (warfarin), for prevention of death, recurrent myocardial infarction, and thromboembolic events, such as stroke after myocardial infarction; and (2) NDA 20-444, Burroughs Wellcome Co., Flolan (epoprostenol), for treatment of primary pulmonary hypertension. On February 24, 1995, the committee will discuss antianginal guidelines.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 10/13/94-10/14/94

Meeting Details:

On October 13, 1994, the committee will discuss drug interactions and antianginal guidelines. On October 14, 1994, the committee will discuss the new drug application (NDA) 20-377 for Cordarone, I.V. amiodarone HCl, Wyeth-Ayerst Laboratories, to be indicated for life-threatening arrhythmias

 

       
Location: October 13 and 14, 1994, 9 a.m., National Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium, 9000 Rockville Pike, Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular & Renal Drugs

Meeting Date: 6/9/94-6/10/94

Meeting Details:

Open committee discussion. On June 9, 1994, the committee will discuss: (1) New drug application (NDA) 20-364, benazepril HC1/ amlodipine besylate, Ciba-Geigy, to be indicated for hypertension and (2) product license application (PLA) 93-1057 (abciximab), CentoRx, Centocor, for high risk angioplasty. On June 10, 1994, the committee will discuss PLA 1048, Supplement #93-0889 (alteplase recombinant), Activase, Genentech, Inc., for new accelerated dose regimen.

 

       
Location: National Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium, 9000 Rockville Pike, Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Broadcasting Live NOW

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/6/14-11/6/14

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Meeting Details:

During the morning session, the committee will discuss New Drug Application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 11/14/14-11/14/14

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Meeting Details:

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. This intraocular lens combines the optical properties of a +3 diopter multifocal intraocular lens with the optical properties of a toric intraocular lens. The proposed indication for use is: The AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens (IOL) are intended for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

 

       
Location: Hilton/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

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Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/12/14-12/12/14

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Meeting Details:

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

       
Location: Holiday Inn-College Park Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/8/14-10/9/14

Meeting Details:

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting on the WATCHMAN device, which was held December 11, 2013. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is indicated to prevent thromboembolism (TE) from the left atrial appendage. It may be considered for use in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism based on CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes, and prior stroke or transient ischemic attack (TIA)) or CHA2DS2-VASc (congestive heart failure, hypertension, age >75 years, diabetes mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category) scores. On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a human valve or valved conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) that alters the original relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until needed by a recipient. An example of such a manufacturing process is one that intentionally removes the cells and cellular debris with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under Product Code OHA, ‘‘Heart Valve, More than Minimally Manipulated Allograft,’’ as unclassified devices and reviewed under the premarket notification, 510(k), authority (21 CFR part 807). FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/23/14-9/23/14

Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Broadcasting Live NOW

Meeting Description:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.


 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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