U.S. FDA advisory meetings through Aug 13
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.
PEDIATRIC ADVISORY COMMITTEE
DATE: June 23, 0830/1230
LOCATION: Hilton Hotel, 1750 Rockville Pike, Rockville, Md.
CONTACT: Carlos Pena, 301-827-3340
The committee will review and discuss reports by the agency, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for privately held Nycomed's asthma drug Alvesco (ciclesonide), Solvay SA's (SOLB.BR) testosterone gel Androgel, Schering-Plough Corp's asthma drug SGP.N Asmanex (mometasone furoate), Allergan Inc's (AGN.N) eye pressure drops Combigan (brimonidine/timolol), Abbott Laboratories' (ABT.N) seizure drug Depakote (divalproex sodium), privately held Hill Dermaceuticals Inc's dermatitis product Derma-Smoothe F/S (fluocinolone acetate), Novartis AG's (NOVN.VX) blood pressure medication Diovan (valsartan), Gilead Sciences Inc's (GILD.O) hepatitis B drug Hepsera (adefovir dipivoxil), Pfizer Inc's hypertension drug (PFE.N) Inspra (eplerenone), MiddleBrook Pharmaceuticals Inc's (MBRK.O) antibiotic Moxatag (amoxicillin), Sepracor Inc's SEPR.O nasal allergy medication Omnaris (ciclesonide), and Novartis' bone drug Zometa (zoledronic acid).
DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE
DATE: June 26, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Paul Tran, 301-827-7001
The committee will discuss a new drug application from Ista Pharmaceuticals (ISTA.O) for Bepreve (bepotastine besilate) ophthalmic solution, 1.5%, for the treatment of ocular itching associated with allergic conjunctivitis, and a new drug application from River Plate Biotechnology Inc for sodium hyaluronate ophthalmic solution for the treatment of the signs and symptoms of dry eye disease. Alcon Inc (ACL.N) holds U.S. marketing rights to River Plate's product.
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE WITH THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE
DATE: June 29-30, 0800/1200
LOCATION: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, Md.
CONTACT: Elaine Ferguson, 301-827-7001 Continued...
