U.S. FDA advisory meetings through Dec 15

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION
UPDATES ITS SCHEDULE. ALL ITEMS EDT/GMT UNTIL NOV. 7 WHEN
EST/GMT RESUMES.

For more information on the FDA’s Advisory Committee
meetings, see:
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds November device meeting)

ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE

DATE: Aug. 19, 0800/1200

LOCATION: Marriott, 5151 Pooks Hill Road, Bethesda, Md.

CONTACT: Kalyani Bhatt, 301-796-9001

The committee will discuss the safety and efficacy of Eli
Lilly and Co’s (LLY.N: ) depression drug Cymbalta, or duloxetine
HCL, for a new indication to treat chronic pain.

ARTHRITIS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK
MANAGEMENT ADVISORY COMMITTEE

DATE: Aug. 20, 0800/1200

LOCATION: Marriott, 5151 Pooks Hill Road, Bethesda, Md.

CONTACT: Anuja Patel, 301-796-9001

The committees will discuss Jazz Pharmaceuticals Inc
(JAZZ.O: ) and UCB SA’s (UCB.BR: ) proposal to sell its drug,
sodium oxybate, for the treatment of adults with fibromyalgia.
Jazz already sells a form of sodium oxybate under the brand
name Xyrem for use in narcolepsy patients.

TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE

DATE: Aug. 30, 0830/1230

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

CONTACT: Cristi Stark, 1-877-287-1373 (choose option 4)

The committee will receive a report from the Tobacco
Product Constituents Subcommittee and discuss a proposed
initial list of harmful or potentially harmful constituents,
the rationale for inclusion of each constituent, established
analytical methods as well as the ancillary methods and
normalization standards for the identified constituents.

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE

DATE: Sept. 7, 0800/1200

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

CONTACT: Minh Doan, 301-796-9001

The committee will discuss Forest Laboratories Inc (FRX.N: )
subsidiary Cerexa Inc’s injectable antibiotic ceftaroline
fosamil for 1) adults with community acquired bacterial
pneumonia and 2) complicated skin and skin structure
infections.

DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE

DATE: Sept. 14, 0800/1200

LOCATION: Marriott Inn and Conference Center, 3501
University Blvd. East, Adelphi, Md.

CONTACT: Elaine Ferguson, 301-827-7001

The committee will discuss the abuse potential of the drug
dextromethorphan and the public health benefits and risks of
dextromethorphan use as a cough suppressant in prescription and
nonprescription drug products. The Department of Health and
Human Services received a request from the Drug Enforcement
Administration for a scientific and medical evaluation and
scheduling recommendation for dextromethorphan in response to
the increased incidence of abuse, especially among
adolescents.

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

DATE: Sept 15-16, 0800/1200

LOCATION: The Marriott Inn and Conference Center,
University of Maryland University College, 3501 University
Blvd. East, Adelphi, Md.

CONTACT: Paul Tran, 301-796-9001

On Sept. 15, the committee will discuss the results of the
Sibutramine Cardiovascular Outcomes Trial (SCOUT) for Abbott
Laboratories Inc’s (ABT.N: ) Meridia (sibutramine hydrochloride
monohydrate) for treatment of obesity. The SCOUT study was a
randomized, double-blind, placebo-controlled trial. The
preliminary results of the SCOUT trial indicated that clinical
trial participants who received MERIDIA instead of placebo had
a higher incidence of major cardiovascular adverse events that
was statistically significant.

On Sept. 16, the committee will discuss the safety and
efficacy of a new drug application from Arena Pharmaceuticals
Inc (ARNA.O: ) for lorcaserin hydrochloride, with the proposed
trade name Lorqess 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 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
high blood pressure, heart disease or diabetes.

PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE

DATE: Sept. 16, 0830/1230

LOCATION: FDA White Oak campus, 10903 New Hampshire Ave.,
Building 31, White Oak Conference Center, room 1503, Silver
Spring, Md.

CONTACT: Yvette Waples, 301-796-9001

The committee will discuss the available safety and
efficacy data for a supplemental new drug application from
Alkermes Inc (ALKS.O: ) for Vivitrol (naltrexone for
extended-release injectable suspension) for the treatment of
opioid dependence.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY
COMMITTEE

DATE: Sept. 21, 1400/1800

LOCATION: National Institutes of Health (NIH), Building
29B/Conference Room C.

CONTACT: Christine Walsh or Denise Royster, 301-827-0314

The committee will hear updates of the research programs
from various laboratories at the Center for Biologics
Evaluation and Research, including the Laboratory of
Respiratory and Special Pathogens in the Division of Bacterial,
Parasitic, and Allergenic Products; the Laboratory of Hepatitis
Viruses as well as the Laboratory of Vector Borne Virus
Diseases in the Division of Viral Products.

RADIOLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY
COMMITTEE

DATE: Sept. 24, 0800/1200

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

CONTACT: Shanika Craig, 301-796-6639

The committee will discuss, make recommendations and vote
on a premarket approval application for the Selenia C Digital
Breast Tomosynthesis System, sponsored by Hologic Inc (HOLX.O: ).
The Selenia C Digital Breast Tomosynthesis System is intended
for use in the same clinical applications as traditional
mammographic systems.

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

DATE: Nov. 18, 0800/1300

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

CONTACT: Margaret McCabe-Janicki, 301-796-7029

The committee will discuss, make recommendations and vote
on MELA Sciences Inc’s (MELA.O: ) MelaFind. The device is a
computer-controlled multispectral dermoscope that uses light to
image the skin through a thin layer of liquid (alcohol or oil).
A complementary metal oxide semiconductor digital camera inside
the probe captures the images and then differentiates them
among pigmented skin lesions for melanoma risk using predefined
software statistical pattern recognition algorithms.

DENTAL PRODUCTS PANEL OF THE MEDICAL DEVICES ADVISORY
COMMITTEE

DATE: Dec 14-15, 0800/1300

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

CONTACT: Olga Claudio, 301-796-7608

The committee will discuss and make recommendations on
scientific issues raised in petitions received by FDA
concerning the final rule on the classification of dental
amalgam, which published in the Federal Register on August 4,
2009. Issues raised in the petitions include the adequacy of
the risk assessment performed by FDA in classifying dental
amalgam in light of a new report on risk assessments issued by
the National Academy of Sciences, entitled Science and
Decisions: Advancing Risk Assessment,” NAP, 2009.
(Reporting by Lisa Richwine, Susan Heavey and Jon Lentz;
Editing by Tim Dobbyn)

U.S. FDA advisory meetings through Dec 15