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U.S. FDA advisory meetings through Jan. 8

Mon, Nov 10 2008, 16:38 GMT
http://www.afxnews.com

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EST/GMT.

ADDS NOTE ABOUT CLOSED SESSION

JOINT MEETING OF THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE

DATE: Nov. 13-14, 0800/1300

LOCATION: Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Md.

CONTACT: Kalyani Bhatt, 301-827-7001

On Nov. 13, 2008, the committees will discuss Pain Therapeutics Inc's experimental drug Remoxy XRT (oxycodone hydrochloride controlled-release) Capsules, and its safety for the proposed indication of managing moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release characteristics of this formulation aim to be less easily tampered with compared to other controlled-release oxycodone formulations.

On Nov. 14, the committees will discuss Alpharma Inc's Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) capsules, and its safety for the proposed indication of managing moderate to severe chronic pain. The naltrexone component of this formulation aims to curb abuse of the product.

NOTE: On both days, the committees will begin with a closed session from 0800/1300 to 0915/1415.

ORTHOPAEDIC AND REHABILITATION DEVICES PANEL

DATE: Nov. 14, 0830/1330

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Ronald Jean, 240-276-3676

The committee will discuss and make recommendations on whether the agency should approve ReGen Biologics Inc's ReGen Collagen Scaffold (CS), which aims to reinforce and repair chronic soft tissue injuries of the meniscus in the knee.

PEDIATRIC ADVISORY COMMITTEE

DATE: Nov. 18, 0800/1300

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Carlos Pena, 301-827-6687

The Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports for Alcon Inc's eye pressure-relieving eye drops Timolol GFS (timolol) and Betoptic S (betaxolol), privately held Graceway Pharmaceuticals LLC's skin cancer cream Aldara (imiquimod), GlaxoSmithKline Plc's epilepsy and bipolar drug Lamictal (lamotrigine), Johnson & Johnson's antibiotic Levaquin (levofloxacin), Novartis AG's hormone disorder drug Sandostatin (octreotide), Eli Lilly and Co's bipolar disorder and schizophrenia drug Zyprexa (olanzapine), Johnson & Johnson's schizophrenia, bipolar mania and autism drug Risperdal (risperidone), Novartis' nail fungus drug Lamisil (terbinafine), and Sanofi Aventis sleep aid Ambien (zolpidem). The committee will also receive a written follow-up report on Pfizer Inc's anti-infective drug Zyvox (linezolid), as requested at the committee's Nov. 16, 2006 meeting.

The committee will also receive updates on other activities, including the June 9 and 10, 2008 Pediatric Ethics Subcommittee meeting.

GENERAL AND PLASTIC SURGERY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: Nov. 18, 0830/1330 and Nov. 19, 0800/1300

LOCATION: Marriott Gaithersburg Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, Md.

CONTACT: Lisa Lim, 240-276-3555

On Nov. 18, the committee will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs and make recommendations on general issues concerning the study of various dermal fillers. In addition, the committee will discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses.

On Nov. 19, the committee will discuss and make recommendations on general issues related to the clinical trials of cosmetic devices. Specifically, the committee will make recommendations on how to quantify the effects of devices with various types of energy sources, such as light-based products, light-based combination devices, ultrasound devices (including focused ultrasound devices), massagers combined with other energy modalities, cryogenic energy devices, radiofrequency ablation devices, and microwave systems, on dermatologic conditions.

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE

DATE: Nov. 18-20, 0800/1300

LOCATION: Holiday Inn, 10000 Baltimore Avenue, College Park, Md.

CONTACT: Janie Kim, 301-827-7001

On Nov. 18, the committee will discuss the justification of the non-inferiority margin for complicated skin and skin structure infections.

On Nov. 19, the committee will discuss a new drug application from Theravance Inc for telavancin powder, for reconstitution and intravenous administration, proposed for the treatment of complicated skin and skin structure infection.

The committee also will discuss a new drug application for oritavancin from Targanta Therapeutics Corp for the treatment of complicated skin and skin structure infection.

On Nov. 20, the committee will discuss a new drug application for iclaprim from Arpida AG, proposed for the treatment of complicated skin and skin structure infection.

CIRCULATORY SYSTEM DEVICES PANEL

DATE: Nov. 20, 0800/1300

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: James Swink, 240-276-4050

The committee will discuss, make recommendations and vote on a premarket approval application sponsored by Johnson & Johnson unit Biosense Webster Inc. for the NaviStar ThermoCool irrigated RF ablation catheter. The device, an open-lumen, irrigated tip, steerable radiofrequency cardiac ablation catheter, is inserted through the venous circulation to the heart, across the intra-atrial septum to the left atrium to ablate cardiac tissue for the purposes of creating lines of block in the atria to eliminate conduction patterns that theoretically generate or allow propagation of paroxysmal atrial fibrillation.

Keywords: FDA ADVISORY/DIARY

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