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).

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.

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.

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.

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.

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

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).

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").

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.

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).

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.

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).

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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).

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.

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.

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, Plavix^TM (clopidogrel bisulfate, Sanofi Pharmaceuticals, Inc.), for prevention of vascular ischemic events in patients with a history of symptomatic atherosclerotic disease.

Meeting Details:

On June 26, 1997, the committee will discuss new drug application (NDA) 19-922, Corlopam^TM (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.

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.

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.

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.

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.

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.''

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.

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.

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

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.

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.

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

Meeting Details:

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. It consists of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated carbon or resins, which may be coated or immobilized to prevent fine particles from entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. Sorbent hemoperfusion systems may also include the machine or instrument used to drive and manage blood and fluid flow within the extracorporeal circuit, as well as any accompanying controllers, monitors, or sensors. On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, if made final, would reclassify sorbent hemoperfusion systems labeled for the treatment of poisoning and drug overdose class II subject to premarket notification [510(k)] and special controls, while sorbent hemoperfusion systems labeled for the treatment of hepatic coma and metabolic disturbances would remain class III requiring premarket approval (PMA) applications. The committee’s discussion will involve making recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of sorbent hemoperfusion devices labeled for the 3 treatment of poisoning and drug overdose. The regulatory history of sorbent hemoperfusion has been discussed as part of a previously published proposed rule (77 FR 9610). During session II on June 27, 2013, the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include various flexible or rigid tubes, such as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff”' for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles. They are similar to subcutaneous catheters. On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, if made final, would make the class III implanted blood access devices class II subject to premarket notification [510(k)] and special controls. The regulatory history of implanted blood access devices has been discussed as part of the proposed rule (77 FR 36951). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm class III or reclassify these devices into class II and comment on 4 whether special controls are adequate to reasonably ensure the safety and effectiveness of this device.

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the risk management of LOTRONEX (alosetron hydrochloride) tablets, by Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.

Meeting Details:

On July 18, 2013, the committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at 3 minutes after administration of rocuronium.

Meeting Details:

On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5- S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

Meeting Details:

On May 22, 2013, the committee will discuss new drug application (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.

Meeting Details:

On May 3, 3013, the committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE, (sargramostim, Genzyme, Inc.), and 125294, TBO–FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs.

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma. During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

Meeting Details:

On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juv[eacute]derm Voluma XC sponsored by Allergan, Inc. Juv[eacute]derm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juv[eacute]derm Voluma XC is indicated for deep (dermal/subcutaneous and/or submuscular/ supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

Meeting Details:

On April 29 and 30, 2013, the Committee will discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA’s adverse event reporting systems, and messaging in the context of competing communicators.

Meeting Details:

On April 25, 2013, during session I, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre- Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Methotrexate,” Product Code LAO, as unclassified under the 510(k) premarket notification authority. Methotrexate enzyme immunoassays are for the quantitative determination of methotrexate. The measurements obtained are used in monitoring levels of methotrexate to ensure appropriate drug therapy. FDA is seeking panel input on the safety and effectiveness of methotrexate enzyme immunoassays. On April 25, 2013, during session II, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. PCP enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Phencyclidine,” Product Code LCM, and “Radioimmunoassay, Phencyclidine,” Product Code LCL, as unclassified under the 510(k) premarket notification authority. FDA is seeking panel input on the safety and effectiveness of PCP enzyme immunoassays and PCP radioimmunoassays. 3 On April 25, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of “Strip, Test Isoniazid,” Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in urine to determine compliance of isoniazid (INH) medication. FDA is seeking panel input on the safety and effectiveness of isoniazid test strips.