FDA Revises Process For Responding To Drug Applications (Medical News Today)
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved.

Meda: FDA Approves Azelastine Eye Drops Unit Dose (Medical News Today)
The U.S. Food and Drug Administration (FDA) has approved Meda's (STO:MEDAA) registration application for azelastine eye drops in unit dose (Optivar Unit Dose). The substance azelastine is an antihistamine and the eye drop formulation is approved for treatment of allergic conjunctivitis in adults and pediatrics.

ViroPharma Provides Update On Upcoming FDA Advisory Committee Meeting To Discuss Bioequivalence Of Locally Acting ... (Medical News Today)
ViroPharma Incorporated (Nasdaq: VPHM) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) (vancomycin hydrochloride capsules) or any other drug products.