U.S. FDA advisory meetings through May 12

TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE

DATE: March 30-31, 0830/1230

LOCATION: National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW, Washington

CONTACT: Cristi Stark, 240-276-3992

On March 30, the committee will cover receive presentations on the background and overview of the FDA Center for Tobacco Products, the Family Smoking Prevention and Tobacco Control Act and the Tobacco Products Scientific Advisory Committee. The committee also will receive presentations on and discuss the published literature on menthol as it relates to the demographics of users, preferential use by persons initiating tobacco use, the health effects of menthol in cigarettes, the effects of menthol on addiction and cessation, marketing and consumer perceptions about menthol cigarettes, the sensory qualities of menthol cigarettes, and the effects of menthol on how cigarettes are smoked.

On March 31, the committee will continue the presentations and discussions of menthol. The committee also will receive preliminary information about topics planned for discussion at future meetings, including an action plan designed to ensure the enforcement of restrictions required by the Tobacco Control Act on the advertising and promotion of menthol and other cigarettes to youth, and the establishment of a list of harmful and potentially harmful tobacco product constituents, including smoke constituents.

These discussions are preliminary to the preparation of the Tobacco Products Scientific Advisory Committee's required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public's health. A second meeting of the Tobacco Products Scientific Advisory Committee, focusing on tobacco industry research and documents related to menthol and cigarettes, is planned for summer 2010.

PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE

DATE: April 7, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Kristine Khuc, 301-827-7001

The committee will discuss new drug application from Forest Laboratories Inc (FRX.N) for Daxas, known generically as roflumilast for the maintenance treatment of chronic obstructive pulmonary disease associated with chronic bronchitis in patients at risk of exacerbations.

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY

DATE: April 13, 0800/1200

LOCATION: Hilton, 8727 Colesville Rd., Silver Spring, Md.

CONTACT: Anuja Patel, 301-827-7001

The committee will receive presentations from the Office of Generic Drugs and discuss two bioequivalence topics relevant to generic drug approval:

(1) Revising the BE approaches for critical dose drugs

(2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications for products with complex pharmacokinetic profiles.

Bioequivalence refers to the evaluation of equivalence in the rate and extent of drug absorption between two preparations of the same drug. Critical dose drugs are medicines that require a narrow (or critical) dose range to achieve and maintain their intended effects and to reduce serious adverse drug reactions. The area under the curve is the area under a plot of drug concentration in the bloodstream versus time; it is a measure of the extent of exposure to a drug after a dose is administered.

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

DATE: May 12, 0800/1200

LOCATION: Hilton, 8727 Colesville Rd., Silver Spring, Md.

CONTACT: Anuja Patel, 301-827-7001

The committees will discuss NicOx SA's (NCOX.PA) new drug application for naproxcinod, a nonsteroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)