Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Committee Meeting June 6, 2013 from 8 a.m. to 5 p.m. (Day 2 of 2) Agenda: 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.

Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Committee Meeting June 5, 2013 from 8 a.m. to 5 p.m. (Day 1 of 2) Agenda: 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.

Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee Committee Meeting May 22, 2013, from 8 a.m. to 5 p.m. Agenda: 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.

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting Committee Meeting May 3, 2013 8:00 a.m. to 5:00 p.m. Agenda: 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.

General and Plastic Surgery Devices Panel of the Medical Devices Meeting

General and Plastic Surgery Devices Panel of the Medical Devices Meeting Committee Meeting May 2, 2013 8:00 a.m. - 6:00 p.m. Agenda: On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juvederm Voluma XC sponsored by Allergan, Inc. Juvederm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juvederm Voluma XC isindicated for deep (dermal/subcutaneous and/or ubmuscular/supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

Meeting of the Oncologic Drugs Advisory Committee Meeting

Meeting of the Oncologic Drugs Advisory Committee Meeting Committee Meeting May 2, 2013 8:00 a.m. to 5:00 p.m. Agenda : 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.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee Committee Meeting April 30, 2013, from 8:30 a.m. to 5:30 p.m. Agenda: Modified risk tobacco products (MRTPs) are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Before an MRTP can be introduced or delivered for introduction into interstate commerce, an order from FDA under section 911(g) (21 U.S.C. 387k(g)) of the Federal Food, Drug, and Cosmetic Act (FD Act) must be in effect with respect to the tobacco product. 21 U.S.C. 387k(a). Any person may submit an application seeking an order under section 911(g) of the FD Act.Show citation box Section 911(f) of the FD Act (21 U.S.C. 387k(f)) requires FDA to refer modified risk tobacco product applications to the Tobacco Products Scientific Advisory Committee (TPSAC) for its recommendations. TPSAC is required to report its recommendations on an application to FDA no later than 60 days after the date the application is referred to them. 21 U.S.C. 387k(f)(2). On April 30, 2013, FDA will present information to the committee on the process it will use to refer individual modified risk tobacco product applications to TPSAC.

Risk Communication Advisory Committee Meeting

Risk Communication Advisory Committee Meeting Committee Meeting April 30, 2013 8:00 a.m. - 12:00 p.m. (Day 2 of 2) Agenda : The Committee will discuss how to communicate effectively about FDA’s adverse event reporting system.

Risk Communication Advisory Committee Meeting

Risk Communication Advisory Committee Meeting Committee Meeting April 29, 2013 8:00 a.m. - 4:00 p.m. (Day 1 of 2) Agenda: The Committee will discuss general factors in risk communication about FDA regulated products, including messaging in the context of competing communicators.

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 26, 2013 8:00 a.m. - 6:00 p.m. (Day 2 of 2) Agenda: On April 26, 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.

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 25, 2013 8:00 a.m. - 6:00 p.m. (Day 1 of 2) Agenda: 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.

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee Committee Meeting April 18, 20138:00 a.m. to 5:00 p.m. Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22219, AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc., for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil microembolism in the lungs and potential anaphylactic reactions. In addition to AVEED, other approved testosterone injectable products will be referenced, especially in regard to oil embolism and potential anaphylactic reactions reported for those products.

Pulmonary-Allergy Drugs Advisory Committee

Pulmonary-Allergy Drugs Advisory Committee Committee Meeting April 17, 2013 8:00 a.m. to 5:00 p.m. Agenda : The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.