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SCHERING CORP. v. FOOD AND DRUG ADMIN.

No. 94-5366.

51 F.3d 390 (1995)

SCHERING CORPORATION, Appellant, v. FOOD AND DRUG ADMINISTRATION.

United States Court of Appeals, Third Circuit.

Decided April 3, 1995.

Attorney(s) appearing for the Case

Robert P. Reznick (argued), Hughes, Hubbard & Reed, Washington, DC (Joseph C. Connors, Maureen O. Chelius, Schering Corp., Kenilworth, NJ, of counsel), for appellant.

Michael A. Chagares, Office of U.S. Atty., Newark, NJ, Frank W. Hunter, Asst. Atty. Gen., Gerald C. Kell, Susan Strawn (argued), Office of Consumer Litigation, Civ. Div., U.S. Dept. of Justice, Washington, DC (Margaret Jane Porter, Chief Counsel, Eric M. Blumberg, Deputy Chief Counsel, Areta L. Kupchyk, Food and Drug Admin., Rockville, MD, of counsel), for appellee.

Before: MANSMANN, HUTCHINSON and McKEE, Circuit Judges.

OPINION OF THE COURT

MANSMANN, Circuit Judge.

The issue before us, brought in the context of a pioneer drug1 manufacturer's challenge to the propriety of FDA approval of non-systemically effective generic drugs pursuant to an abbreviated approval process, is one of first impression in the courts of appeals. We must determine whether the bioequivalence requirements, set forth in section...

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