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.

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.

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).

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.

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.)

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.

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.

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.

Meeting Details:

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

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.

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.

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.

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.

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.

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.

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.

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).

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).

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.

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.”

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.

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.

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.

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.

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.

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.

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.

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,''

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.

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.

Meeting Details:

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

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.

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.

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.

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.

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.

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.

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.

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.

Meeting Details:

On November 19, 1997, the committee will discuss new drug application (NDA) 20-741, Prandin^TM 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, Evista^TM (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.

Meeting Details:

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

Meeting Details:

The committee will discuss obesity drug guidelines.

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.

Meeting Details:

On May 21, 2013, the committee will discuss and make recommendations regarding the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. The class III shortwave diathermy is a device that applies electromagnetic energy to the body in a radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make shortwave diathermy devices for all other uses class III requiring premarket approval (PMA) applications. In response to the proposed rule calling for PMAs, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA- 2012-N-0378. The prior regulatory history of shortwave diathermy for all other uses has been discussed as part of the proposed rule (77 FR 39953). The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to PMA), or reclassify to class I or class II (subject to premarket notification (510(k))), as directed by section 515(i) of the FD&C Act. 3 On May 22, 2013, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (Docket No. FDA-2009-M-0101), for one of the remaining preamendments class III devices, pedicle screw spinal systems, intended to treat degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1, or degenerative spondylolisthesis with objective evidence of neurologic impairment. Pedicle screw spinal systems are posterior spinal screw and rod systems intended as an adjunct to fusion for the treatment of degenerative disc disease, trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the thoracolumbar spine. On July 27, 1998 (63 FR 40025), FDA published a final rule classifying certain previously unclassified preamendments pedicle screw spinal systems and reclassifying certain postamendments pedicle screw spinal systems. On May 22, 2001 (66 FR 28051), FDA published a technical amendment to the final rule to include an intended use that was inadvertently omitted from the codified language in the rule. As described in the summary of revisions in the technical amendment, FDA changed the intended uses for which pedicle screw spinal systems are class III from “all other uses,” to “when intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.” Since the technical amendment, FDA has not established an effective date for the submission of PMAs for pedicle screw spinal systems with these class III indications for use; consequently, these systems have been subject to 510(k). 4 The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to PMA), or reclassify to class I or class II (subject to 510(k)), as directed by section 515(i) of the FD&C Act.

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 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 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:

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 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.