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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/1/14-4/1/14

Meeting Details:

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

 

       
Location: College Park Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 12/11/13-12/12/13

Meeting Details:

On December 11th - The committee will discuss the safety and efficacy of biologic licensing application (BLA) 125390, metreleptin for injection, sponsored by Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of Bristol Myers Squibb. The proposed indication for metreleptin is the treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or hypertriglyceridemia (elevated triglyceride levels in the blood) in pediatric and adult patients with inherited or acquired lipodystrophy. (Lipodystrophies are rare medical conditions of abnormal loss of the body's fatty tissues.) On December 12th - The committee will discuss the efficacy and safety of new drug application (NDA) 202293, dapagliflozin tablet, submitted by Bristol-Myers Squibb. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 11/19/13-11/19/13

Meeting Details:

The committee will discuss biologics license application (BLA) 125460, for Vimizim (elosulfase alfa), manufactured by BioMarin Pharmaceutical, Inc., for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital disorder caused by the absence or malfunctioning of an enzyme involved in an important metabolic pathway, leading to problems with bone development, growth and movement.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drug AdComm

Meeting Date: 10/16/13-10/16/13

Meeting Details:

On October 16, 2013, the committee will discuss the supplemental new drug application 202057/S-005, VASCEPA (icosapent ethyl) capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. VASCEPA is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides, non-high density lipoprotein cholesterol, apolipoprotein B, low-density lipoprotein cholesterol, total cholesterol, and very low density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Endocrinologic & Metabolic and Drug Safety/Risk MGMT

Meeting Date: 6/5/13-6/6/13

Meeting Details:

On June 5 and 6, 2013, the committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 1/10/13-1/10/13

Meeting Details:

The committee will discuss new drug application (NDA) 204042, canagliflozin tablets, proposed trade name INVOCANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic AdComm - NovoNordisk

Meeting Date: 11/8/12-11/8/12

Meeting Details:

The committee will discuss the safety and efficacy of new drug applications (NDAs) 203313, insulin degludec/insulin aspart [rDNA origin] injection and 203314, insulin degludec [rDNA origin] injection, manufactured by Novo Nordisk Inc. The proposed indication (use) for these applications is for the treatment of Type 1 and Type 2 diabetes mellitus.

 

       
Location: Silver Spring, MD Related News Links: Not Available
Time: 7:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic AdComm - Singifor by Novartis

Meeting Date: 11/7/12-11/7/12

Meeting Details:

The committee will discuss the safety and efficacy of a new drug application (NDA) 200677, pasireotide injection (proposed trade name SIGNIFOR) for subcutaneous administration, submitted by Novartis Pharmaceuticals Corporation. Pasireotide is an analog (a chemical compound that resembles another compound in structure) of somatostatin. The proposed indication (use) for pasireotide injection is the treatment of patients with Cushing’s disease who require medical intervention (Cushing’s disease is a rare medical condition of excessive cortisol secretion that is secondary to a tumor located in the pituitary gland).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/18/12-10/18/12

Meeting Details:

The committee will discuss new drug application (NDA) 203568, mipomersen injection, by Genzyme Corporation. The proposed indication (use) is as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce low-density lipoprotein (LDL) cholesterol, apolipoprotein B, total cholesterol, non-high density lipoprotein-cholesterol and lipoprotein (a) in patients with homozygous familial hypercholesterolemia.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/17/12-10/17/12

Meeting Details:

The committee will discuss new drug application (NDA) 203858, lomitapide capsules, by Aegerion Pharmaceuticals, Inc. The proposed indication (use) is as an adjunct to a low-fat diet and other lipid-lowering drugs with or without low-density lipoprotein (LDL) apheresis to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and triglycerides in patients with homozygous familial hypercholesterolemia. (Apheresis is a laboratory technology used to remove LDL from the bloodstream.)

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs

Meeting Date: 5/10/12-5/10/12

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 22–529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

 

       
Location: DoubleTree by Hilton Hotel Washington, DC-Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 3/28/12-3/29/12

Meeting Details:

On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 2/22/12-2/22/12

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery

Meeting Date: 12/14/11-12/14/11

Meeting Details:

To provide advice and recommendations to the Agency on scientific disputes between CDRH and sponsors, applicants, and manufacturers.

 

       
Location: Hilton Washington, DC/North Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee;

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

Meeting Details:

On November 2, 2011, the committee will discuss supplemental new drug applications 21-687 and 21-445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering-Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3- hydroxy-3-methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipids in the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDapagliflozin by BMS and AZ - EMDAC

Meeting Date: 7/19/11-7/19/11

Meeting Details:

On July 19, 2011, the committee will discuss new drug application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAbbott (TRILIPIX) - Endocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/19/11-5/19/11

Meeting Details:

On May 19, 2011, the committee will discuss the findings of the Action to Control Cardiovascular Risk in Diabetes-Lipid (ACCORD Lipid) trial as they relate to the efficacy and safety of the approved new drug application (NDA) 22224, TRILIPIX (fenofibric acid) delayed release capsules, manufactured by Abbott Laboratories. TRILIPIX (fenofibric acid), an active form of fenofibrate, is indicated for use in combination with a 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor, commonly referred to as a “statin”, to lower high levels of serum triglycerides and raise low levels of highdensity lipoprotein cholesterol in patients with mixed dyslipidemia and coronary heart disease (CHD) or CHD risk equivalent who are on optimal statin therapy to achieve their low-density lipoprotein cholesterol goal. The ACCORD Lipid study was a randomized, double-blind, placebo-controlled add-on trial, which is the kind of clinical trial designed to provide data with strong measures of accuracy and reliability. The ACCORD Lipid study evaluated the efficacy and safety of adding fenofibrate therapy to treatment with the statin, simvastatin in subjects with type 2 diabetes mellitus. The results of the ACCORD Lipid trial indicated that there was no statistically significant difference in the proportion of clinical trial subjects treated with simvastatin plus placebo verus simvastatin plus fenofibrate who experienced a major adverse cardiac event. In a prespecified subgroup analysis from the ACCORD Lipid trial, there was an increase in the proportion of female trial subjects treated with simvastatin plus fenofibrate versus simvastatin plus placebo who experienced a major adverse cardiac event. The clinical significance of this finding is unclear. 3 An additional safety concern associated with the use of fenofibrate plus simvastatin, or any other statin, is muscle toxicity.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 12/7/10-12/7/10

Meeting Details:

On December 7, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 20-0063, proposed tradename CONTRAVE (naltrexone HCl/bupropion HCl) extended-release tablets, manufactured by Orexigen Therapeutics, Inc., for the treatment of obesity and weight management, including weight loss and maintenance of weight loss in patients with an initial body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter with one or more risk factors (e.g. diabetes, dyslipidemia, or hypertension). The BMI is a measure of body weight (mass) based on a person’s weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 9/15/10-9/16/10

Meeting Details:

On September 15, 2010, the committee will discuss the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01392), for new drug application (NDA) 20632, MERIDIA (sibutramine hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories, for treatment of obesity. The SCOUT study was a randomized, double-blind, placebo-controlled trial, which is a kind of clinical trial designed to provide data with strong measures of accuracy and reliability. The SCOUT trial evaluated the potential benefits of weight loss with MERIDIA on major cardiovascular (heart and blood circulation) adverse events. The preliminary results of the SCOUT trial indicated that clinical trial participants who received MERIDIA instead of placebo (no active drug) had a higher incidence of major cardiovascular adverse events that was statistically significant. On September 16, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22529, with the proposed trade name LORQESS (lorcaserin hydrochloride) Tablets, sponsored by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities (which include, for example: High blood pressure, heart disease, or diabetes). The BMI is a measure of body weight (mass) based on a person's weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 7/15/10-7/15/10

Meeting Details:

On July 15, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22–580, proposed tradename, QNEXA (phentermine/topiramate) Controlled Release Capsules by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index of 30 kilograms (kg) per square meter, or a body mass index equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Endocrinologic & Metabolic and DSRM AdComm

Meeting Date: 7/13/10-7/14/10

Meeting Details:

On both days, the committees will focus primarily on the cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets, GlaxoSmithKline, a drug approved for blood glucose control in adults with type 2 diabetes mellitus. Data specific to rosiglitazone to be presented will include results from the Rosiglitazone Evaluated for Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, observational data, health claims data, and a meta-analysis of controlled clinical trials. In addition, the FDA will present its meta-analysis of several trials of ACTOS (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals North America, Inc., another thiazolidinedione for the same indication, in response to public documents comparing the safety of rosiglitazone to pioglitazone based on different meta-analyses performed on each of these two drugs.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 7:45AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/27/10-5/27/10

Meeting Details:

On May 27, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).

 

       
Location: The Inn and Conference Center Adelphi, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Endocrinologic and Metabolic Drugs AdComm

Meeting Date: 2/24/10-2/24/10

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 22505, for EGRIFTA (tesamorelin acetate) sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 1/12/10-1/13/10

Meeting Details:

On January 12, 2010, the committee will discuss new drug application (NDA) 21348, ZAVESCA (miglustat), 100 milligram (mg) capsules, by Actelion Pharmaceuticals, Ltd., proposed for the treatment of progressive neurological manifestations (symptoms related to the nervous system) in patients with Niemann-Pick Disease (type C). On January 13, 2010, the committee will discuss NDA 22562, CARBGLU (carglumic acid), 200 mg tablets, by Orphan Europe SARL, proposed for the treatment of hyperammonemia (elevated levels of ammonia in the blood) in patients with N acetyl glutamate synthetase (NAGS) deficiency, an inherited disorder that causes ammonia to accumulate in the blood.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 12/15/09-12/15/09

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 21-366, CRESTOR (rosuvastatin calcium) tablets, AstraZeneca Pharmaceuticals. CRESTOR is a member of the statin drug class which lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting HMG-CoA reductase, an enzyme involved in producing lipids in the body. The proposed indication (use) of CRESTOR in this application is primary prevention of cardiovascular disease based on the results of JUPITER. JUPITER was a clinical trial that studied individuals who did not have obvious or overt cardiovascular disease, but did have the following characteristics: Low or normal levels of the variety of cholesterol known as low-density lipoprotein, or LDL; elevated levels of C-reactive protein (hsCRP), a marker of inflammation in the body, and at least one of the conventional risk factors for cardiovascular disease. (The “conventional risk factors” are smoking, age, high blood pressure, low levels of the good cholesterol, HDL, and a family history of heart disease). In these individuals, JUPITER evaluated the reduction of risk with rosuvastatin therapy on the study’s combined objectives (known as the study’s “composite endpoint”) which included: Death from heart disease (heart attack) or vascular disease (stroke), heart attack that did not result in death, stroke that did not result in death, unstable angina (when the heart does not get enough blood flow, often a warning of heart attack), and heart or blood vessel disease that necessitates arterial revascularization, commonly known as “bypass surgery.”

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/1/09-4/2/09

Meeting Details:

On April 1 and 2, 2009, two different new drug applications (NDAs), proposed for the treatment of hyperglycemia in adults with type 2 diabetes mellitus will be discussed. On April 1, 2009, the committee will discuss NDA 22350, saxagliptin tablets, Bristol-Myers Squibb, and on April 2, 2009, the committee will discuss NDA 22341, liraglutide injection, Novo Nordisk, Inc.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/21/08-10/21/08

Meeting Details:

On October 21, 2008, the committee will begin with a closed session from 8 a.m. to 11 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 the safety and efficacy of biologic license application (BLA) 125291, MYOZYME (alglucosidase alfa), Genzyme Corp., for the treatment of late onset Pompe disease.

 

       
Location: Silver Spring MD Related News Links: Not Available
Time: 11:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 7/1/08-7/2/08

Meeting Details:

On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of type 2 diabetes mellitus.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint ENDAC and DSRM AdComm

Meeting Date: 7/30/07-7/30/07

Meeting Details:

Agenda: The Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees will meet in joint session to discuss the cardiovascular ischemic/thrombotic risks of the thiazolidinediones, with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 6/13/07-6/13/07

Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 21-888, proposed tradename Zimulti (rimonabant), 20 milligrams tablets, Sanofi-Aventis, as an adjunct to diet and exercise for obesity management in patients with a body mass index equal to or greater than 30 kilograms (kg) per square meter, or a body mass index equal to or greater than 27 kg per square meter if accompanied by at least one cardiovascular risk factor.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Endo and Pharm Science AdComm

Meeting Date: 10/4/06-10/4/06

Meeting Details:

The joint committee will discuss FDA's efforts to assess the product quality of currently marketed levothyroxine sodium drug products. Earlier this year, FDA requested that manufacturers of currently marketed levothyroxine sodium products provide to it certain product release and stability information. The joint committee will consider FDA's analyses and any clinical significance.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 9/8/05-9/9/05

Meeting Details:

On September 8, 2005, the committee will discuss new drug application (NDA) 21-868, proposed trade name EXUBERA (insulin recombinant deoxyribonucleic acid (rDNA) origin powder for oral inhalation), 1 milligram (mg) and 3 mg powder for inhalation, Pfizer, Inc., for the treatment of adult patients with diabetes mellitus. On September 9, 2005, the committee will discuss new drug application (NDA) 21-865, proposed trade name PARGLUVA (muraglitazar) Tablets, 2.5 mg and 5 mg, Bristol-Myers Squibb, for the treatment of type II diabetes mellitus.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs Advisory Committee

Meeting Date: 9/8/04-9/9/04

Meeting Details:

On September 8, 2004, the committee will discuss the FDA draft guidance document entitled ``Guidance for the Clinical Evaluation of Weight-Control Drugs,''

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 10/7/03-10/7/03

Meeting Details:

On October 7th, the committee will discuss the Womens Health Initiative (WHI) study results, implications for the use of hormone therapy with estrogen progestin as a second line drug in the treatment and prevention of postmenopausal osteoporosis in women.

 

       
Location: HOL - Beth Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs Adcomm

Meeting Date: 7/9/03-7/9/03

Meeting Details:

On July 9, 2003, the committee will discuss AstraZeneca's Lipid-lowering medication CRESTOR® (rosuvastatin calcium)receives FDA review. For the proposed indication of treatment of Hypercholesterolemia.

 

       
Location: HOL - Beth Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs Advisory Committee

Meeting Date: 6/10/03-6/10/03

Meeting Details:

On June 10, 2003, the committee will discuss Lilly’s Humatrope.

 

       
Location: HOL - Beth Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndoMeta Drugs Advisory Committee
Genzyme, Transkaryotic & BioMarin

Meeting Date: 1/13/03-1/15/03

Meeting Details:

On January 13, 2003, the committee will discuss the safety and efficacy of biologic licensing application BL 103979, FABRAZYME (agalsidase beta, Genzyme Corp.) for the treatment of Fabry's disease. On January 14, 2003, the committee will discuss the safety and efficacy of biologic licensing application BL 103977, REPLAGAL (agalsidase alfa, Transkaryotic Therapies, Inc.) for the treatment of Fabry's disease. On January 15, 2003, the committee will discuss the safety and efficacy of biologic licensing application BL 125058, ALDURAZYME (laronidase, BioMarin Pharmaceutical, Inc.) for the treatment of mucopolysaccharidosis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndoMeta Drugs Advisory Committee

Meeting Date: 9/25/02-9/27/02

Meeting Details:

On September 25, 2002, the committee will discuss appropriate designs for clinical trials of new osteoporosis treatments. On September 26, 2002 the committee will discuss the safety and efficacy of biologic licensing application BL 103979, Fabrazyme (agalsidase beta, Genzyme Corporation) for the treatment of Fabry’s disease. On September 27, 2002, the committee will discuss the safety and efficacy of biologic licensing application BL 103977, Replagal (agalsidase alfa, Transkaryotic Therapies) for the treatment of Fabry’s disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory

Meeting Date: 7/26/01-7/27/01

Meeting Details:

On July 26, 2001, the committee will discuss new drug application (NDA) 21-332, SymlinTM (pramlintide acetate, Amylin Pharmaceuticals, Inc.) as an adjunctive therapy to insulin to improve glycemic and metabolic control in patients with type 1 or type 2 diabetes mellitus alone or in combination with oral hypoglycemic agents. On July 27, 2001, the committee will discuss NDA 21-318, ForteoTM (teriparatide injection, rDNA origin, Eli Lilly and Co.) for the treatment of osteoporosis in men and in postmenopausal women.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic

Meeting Date: 5/19/00-5/19/00

Meeting Details:

On May 19, 2000, FDA's Endocrine & Metabolic Drugs Committee will heard the FDA's presentation on the agency's rationale for the March 21 withdrawal from the U.S. market of Warner-Lambert's Rezulin (troglitazone) type 2 diabetes therapy.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 10:00AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 4/22/99-4/23/99

Meeting Details:

On April 22, 1999, the Committee will discuss the safety and efficacy of new drug application (NDA) 21-071, Avandia™, (rosiglitazone, SmithKline Beecham) for the treatment of hyperglycemia in type 2 diabetes mellitus, as monotherapy and in combination with metformin. On April 23, 1999, the Committee will discuss the safety and efficacy of new drug application (NDA) 21-073, Actos™, (pioglitazone, Takeda Pharmaceuticals) to improve glycemic control in patients with type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 3/26/99-3/26/99

Meeting Details:

The committee will discuss experience since approval for marketing, benefits, and risks of Rezulin (troglitazone, Parke-Davis Pharmaceutical Research, a Division of Warner-Lambert) in the treatment of type 2 diabetes mellitus.

 

       
Location: Holiday Inn Versailles Ballrooms I and II 8120 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 5/13/98-5/15/98

Meeting Details:

On May 13, 1998, the Committee will discuss the science of corticosteroid induced osteoporosis. On May 14, 1998, the Committee will discuss new drug application (NDA) 20-866, Ergoset™, (bromocryptine mesylate, Ergoscience) as monotherapy as an adjunct to diet to improve glycemic control in patients with non-insulin dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be satisfactorily managed with diet alone; or concomitantly with a sulfonylurea when diet and Ergoset™ alone do not result in glycemic control. On May 15, 1998, the committee will discuss NDA 20-898, Thyrogen™ (thyrotropin alpha, rTSH, Genzyme) an adjunct for the detection of thyroid cancer.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 3/12/98-3/13/98

Meeting Details:

March 12, the Committee will discuss a proposed draft of a guidance document for the development of drugs for the treatment of diabetes mellitis. On March 13, the Committee will discuss New Drug Application, XenicalTM, (orlistat tetrahydrolipstatin, Hoffman-LaRoche) for long term treatment of obesity.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 11/19/97-11/20/97

Meeting Details:

On November 19, 1997, the committee will discuss new drug application (NDA) 20-741, PrandinTM or Actulin TM (repaglinide, Novo Nordisk) for the treatment of type 2 diabetes in patients whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. On November 20, 1997, the committee will discuss NDA 20-815, EvistaTM (raloxifene hydrochloride, Eli Lilly and Co.) for the prevention of postmenopausal osteoporosis. On November 21, 1997, the committee will meet in closed session to permit discussion and review of trade secret and/or confidential information.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 5/14/97-5/14/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding new drug application 20-766, XenicalTM (orlistat, tetrahydrolipstatin, Hoffman-LaRoche, Inc.) for long-term treatment of obesity.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 5/13/97-5/13/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the switch from prescription to over-the-counter status of new drug application (NDA) 16-640/S072, Questran Powder (cholestyramine resin) and NDA 19-669/S020, Questran Light (cholestyramine resin with aspartame), Bristol Myers Squibb, for the reduction of elevated serum cholesterol.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 2/20/97-2/20/97

Meeting Details:

On February 20, 1997, the committee will hear presentations and discuss data submitted regarding NDA 20-560/S- 003, Fosamax (alendronate sodium tablets, Merck & Co.) for an expansion of the indication to include the prevention of postmenopausal osteoporosis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 12/10/96-12/11/96

Meeting Details:

On December 10, 1996, the committee will hear presentations and discuss data submitted regarding new drug application (NDA) 20-656, Nutropin(somatropin [rDNA origin] for injection, Genentech, Inc.) and NDA 19-640/S-018, Humatrope (somatropin [rDNA origin] for injection, Eli Lilly and Co.) for the treatment of Turner's Syndrome. On December 11, 1996, the committee will hear presentations and discuss data submitted regarding NDA 20-720, Rezulin TM (troglidizone, Parke Davis Pharmaceutical Research, a Division of Warner-Lambert) and NDA 20-719, Prelay TM (troglidizone, Sankyo U.S.A.) for the treatment of type II diabetes inadequately controlled with insulin therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 9/26/96-9/26/96

Meeting Details:

The committee will hear presentations and discuss the safety and efficacy of a new drug application (NDA) 20- 632, sibutramine hydrochloride monohydrate, (Meridia TM, Knoll Pharmaceutical Co.) for weight loss in obesity.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 8/15/96-8/15/96

Meeting Details:

On August 15, 1996, the committee will hear presentations and engage in scientific discussion on recent developments in technique and measurement of body composition.

 

       
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 Endocrinologic and Metabolic and the Antiviral Drugs Advisory Committee

Meeting Date: 3/1/96-3/1/96

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the safety and efficacy of NDA 20- 604, Serostim, (somatropin [rDNA], Serono Laboratories, Inc.) for treatment of AIDS-wasting associated with catabolism, weight loss or cachexia.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 2/29/96-2/29/96

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the safety and efficacy of NDA 20- 563, Humalog , (insulin lispro [rDNA origin], Eli Lilly) for treatment of insulin dependent diabetes mellitis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 11/16/95-11/17/95

Meeting Details:

On November 16, 1995, the committee will hear presentations and discuss data submitted regarding the safety and efficacy of dexfenfluramine hydrochloride, NDA 20-344 (Redux, Interneuron Pharmaceuticals, Inc.), for an obesity indication, as followup to the meeting of September 28, 1995. On November 17, 1995, the committee will hear presentations and discuss data submitted regarding the safety and efficacy of sodium fluoride USP, NDA 19-975 (Slow Fluoride, Texas Southwest Medical Center), for an osteoporosis indication.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 9/28/95-9/28/95

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the safety and efficacy of dexfenfluramine hydrochloride, NDA 20-344, Interneuron Pharmaceuticals, Inc., for an obesity indication.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Endocrinologic & Metabolic Drugs

Meeting Date: 9/27/95-9/27/95

Meeting Details:

Nonprescription Drugs Advisory Committee and some members of the Endocrinologic and Metabolic Drugs Advisory Committee will discuss public health issues relevant to cholesterol lowering regimens and data relevant to new drug application (NDA) 16-640 for cholestyramine (Questran powder) and NDA 19-669 for cholestyramine (Questran Light with aspartame), sponsored by Bristol-Myers Squibb to switch the products from prescription to over-the-counter marketing status for use as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein (LDL) cholesterol) who do not respond adequately to diet.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Fertility & Maternal Health Drugs/ Generic Drugs /Endocrinologic & Metabolic Drugs

Meeting Date: 7/27/95-7/28/95

Meeting Details:

The committee will discuss the necessary components of conjugated estrogens as they relate to clinical efficacy of conjugated estrogens and other estrogen replacement drug products for approved indications.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 7/13/95-7/13/95

Meeting Details:

On July 13, 1995, the committee will hear presentations and discuss data submitted regarding the safety and efficacy of alendronate, new drug application (NDA) 20-560 (Fosamax, Merck), for an osteoporosis indication. On July 14, 1995, the committee will discuss guidance criteria for the development of safe and effective medications for the treatment of obesity.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 6/1/95-6/1/95

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the safety and efficacy of acarbose, new drug application 20-482, (Precose, Bayer Corp.), for a non-insulin dependent diabetes mellitus indication. Working Group Meeting of the Food Advisory Committee

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

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

Meeting Details:

On February 23, 1995, the committee will hear presentations and discuss data submitted regarding the safety and efficacy of sermorelin acetate, NDA 20-443 (Geref, Serono), for a growth hormone insufficiency indication. On February 24, 1995, the committee will discuss nilutamide, NDA 20-169 (Anandron, Roussel Uclaf), for a prostate cancer indication.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 1/19/95-1/20/95

Meeting Details:

The committee will discuss obesity drug guidelines.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic & Metabolic Drugs

Meeting Date: 11/17/94-11/18/94

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the safety and efficacy of the following: (1) Etridronate disodium/calcium carbonate, new drug application (NDA 20-082), (Didrocal, Proctor and Gamble); (2) calcitonin (nasal spray), NDA 20-313, (Miacalcin, Sandoz Pharmaceutical); and (3) calcitonin (injectable), NDA 17-769 (Calcimar, Rhone-Poulenc-Rorer), for an osteoporosis indication. Closed presentation of data. On November 17, 1994, the committee will hear trade secret and/or confidential commercial information relevant to pending investigational new drug applications.

 

       
Location: November 17 and 18, 1994, 8:30 a.m., Holiday Inn--Gaithersburg, Goshen Room, Two Montgomery Village Ave., Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

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Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

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

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

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

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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 OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

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

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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 OptionsMeeting OptionsMeeting Options| Methodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

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Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

Meeting Date: 9/11/14-9/11/14

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (NPS Pharma)

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

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Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Bone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

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Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| FDA’s GDUFA Public Hearing on Policy Development

Meeting Date: 9/17/14-9/17/14

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Meeting Details:

FDA is hosting the Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation. FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. We will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.

 

       
Location: College Park Marriott Hotel and Conference Center 3501 University Boulevard East Hyattsville, MD 20783 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Pediatric AdComm

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

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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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Gastroenterology and Urology Devices Panel

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

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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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

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

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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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

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

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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    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 8/14/14-8/14/14

Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

Meeting Date: 8/11/14-8/11/14

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Comm

Meeting Date: 7/31/14-7/31/14

Meeting Details:

On the morning of July 31, 2014, the committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the Committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

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

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