Schering appeal of FDA bioequivalence reg denied by Supreme Court.
Executive Summary
SCHERING BIOEQUIVALENCE APPEAL REJECTED BY SUPREME COURT via an Oct. 2 denial of the company's petition for a writ of certiorari in the matter of Schering v. FDA concerning possible generic competition for the company's metered-dose albuterol inhaler Proventil. Schering-Plough challenged FDA's 1992 regulation implementing the Waxman/Hatch Act, which the company asserts unfairly broadened the ANDA provisions of the 1984 act.