Arthritis Advisory Committee

Arthritis Advisory Committee Committee Meeting December 20, 2012, from 8 a.m. to 5 p.m. Agenda: The committee will discuss new drug application (NDA) 22151, rintatolimod injection (proposed trade name AMPLIGEN), submitted by Hemispherx Biopharma, Inc., for the treatment of patients with chronic fatigue syndrome.

Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting December 13, 2012 8:00 a.m. to 3:30 p.m. (Day 2 of 2) On December 13, 2012 the committee will discuss two common risk management tools used to minimize the risk of teratogens – contraception and pregnancy testing. The committee will discuss considerations for standardizing recommendations for use of these two tools.

Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting : December 12, 2012 8:00 a.m. to 5:30 p.m. (Day 1 of 2) 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 CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans to present information on the risk management of teratogens, some of which have REMS with ETASU. On December 12, 2012, the DSaRM advisory committee will meet to discuss the various strategies used by the Agency to define and address teratogenic risk, including requiring REMS with ETASU. The discussion will include an evaluation of the different strategies and the decision framework for selecting risk management strategies for teratogens. The committee will discuss whether the risk management strategies, including REMS with ETASU, assure safe use, are not unduly burdensome to patient access to the drug, and to the extent practicable, minimize the burden to the health care delivery system.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee Committee Meeting December 10, 2012 8:00 a.m. - 5:00 p.m. Agenda: On December 10, 2012, the committee will discuss current knowledge about the safety and effectiveness of the CoAxia NeuroFlo Catheter device for the intended use of diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke within 14 hours of symptom onset. The CoAxia NeuroFlo Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. The proximal end has a multi-port manifold which provides access for the guidewire, monitoring of blood pressure, and independent inflation of the individual balloons. The device is placed in the descending aorta. On March 30, 2005, a Humanitarian Device Exemption application for the CoAxia NeuroFlo Catheter was approved for the following indication for use: The CoAxia NeuroFlo Catheter is intended for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage (SAH), secured by either surgical or endovascular intervention for patients who have failed maximal medical management. Of note, the CoAxia Neuroflo Catheter is identical in design to the Coaxia FloControl which is currently cleared for the following general indications for use: The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature (K023914). The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta (K090970). CoAxia has submitted a de novo application for the NeuroFlo Catheter for the following indication: The CoAxia NeuroFlo Catheter is intended for use in diversion of cardiac output via partial occlusion of the descending aorta, including patients with acute ischemic stroke within 14 hours of symptom onset. The CoAxia NeuroFlo Catheter is also intended for use in selectively stopping or controlling blood flow in the peripheral vasculature, which includes the descending aorta. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. In particular, the panel will be asked to discuss the safety and effectiveness data from the “Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)” clinical trial as they relate to the proposed indications for use.

Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee

Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Committee Meeting : December 7, 2012 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss the risks and benefits of new drug application (NDA) 202880, by Zogenix Inc., for hydrocodone bitartrate extended-release capsules (proposed trade name Zohydro ER), an opioid analgesic medication for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This formulation of hydrocodone bitartrate extended-release capsules represents the first single-entity (i.e., containing no other active pharmaceutical ingredients, such as acetaminophen or ibuprofen) hydrocodone-containing drug product. It will be formulated in dose strengths up to 50 mg, and administered twice daily (i.e., every 12 hours). The committee will be asked to determine whether the benefit-risk assessment of this product favors its approval for marketing

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Committee Meeting : December 5-6, 2012 8:00 a.m. - 6:00 p.m. (Day 2 of 2) Agenda: On December 6, 2012, 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 Nonroller-type cardiopulmonary bypass blood pumps, one of the remaining pre-Amendment Class III devices. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump blood. There are two types of nonroller-type pumps which have been reviewed by the Agency: 1) Centrifugal type pumps utilize a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. These pumps are part of an extracorporeal circuit usually containing an oxygenator and are intended to provide cardiopulmonary support, during procedures such as cardiopulmonary bypass surgery, for periods lasting 6 hours or less. 2) Micro-axial type pumps are comprised of a pump motor, a cannula and a catheter that connects to a console. These pumps are not designed to be used with an oxygenator but are temporarily placed within the heart or vasculature to provide cardiac support only.

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Committee Meeting : December 5, 2012 8:00 a.m. - 6:00 p.m. (Day 1 of 2) Agenda: On December 5, 2012, during session I, 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 the external counter-pulsating (ECP) devices, one of the remaining pre-Amendment Class III devices. These systems typically consist of a treatment table, pressure cuffs and a controller. They are intended to provide noninvasive circulatory support by applying external pressure to the lower extremities during diastole to increase coronary perfusion pressure, and releasing external pressure during systole to reduce left ventricular workload.

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Committee Meeting December 4, 2012 8:00 a.m. to 5:30 p.m. Agenda: The subcommittee will receive a presentation on pediatric provisions mandated by the Food and Drug Administration Safety and Innovation Act. This will be an awareness presentation and there will not be a formal Committee discussion or recommendation. In addition, information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.

Anti-Infective Drugs Advisory Committee Meeting

Anti-Infective Drugs Advisory Committee Meeting Committee Meeting November 29, 2012 8:00 a.m. to 5:00 p.m. (Day 2 of 2) Agenda: On November 29, 2012, the committee will discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride) sterile powder for injection, submitted by Theravance, Inc., for the requested indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia (VAP), caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and –resistant isoloates) or Streptococcus pneumoniae (penicillin susceptible strains).

Anti-Infective Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee Committee Meeting November 28, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: On November 28, 2012, the committee will discuss the safety and effectiveness of new drug application (NDA) 204384, bedaquiline tablets, submitted by Janssen Therapeutics, Division of Janssen Products, LP. The proposed indication (use) for this product is for the treatment of patients with multi-drug resistant pulmonary tuberculosis.