U.S. FDA advisory meetings through May 12

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.

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY

DATE: April 14, 0800/1200

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

CONTACT: Anuja Patel, 301-827-7001

The committee will receive presentations from the Office of Generic Drugs on a proposal for revision of the bioequivalence approaches, specifically to discuss the addition of a limitation on point estimates. The committee also will receive presentations on an awareness topic to highlight some issues associated with product instability (failure of a marketed product to meet stability specifications through the expiration date), and the potential research needs to address those issues. In addition, the committee will receive and discuss presentations from Office of Pharmaceutical Science on the regulatory challenges of drug-induced phospholipidosis (excessive intracellular accumulation of phospholipids, a kind of fatty molecule, due to the use of certain drugs).

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

DATE: May 12, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, 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)