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SCHERING CORP. v. SULLIVAN

Civ. A. No. 90-1804(MB).

782 F.Supp. 645 (1992)

SCHERING CORPORATION, Plaintiff, v. Louis W. SULLIVAN, et al., Defendants.

United States District Court, District of Columbia.

January 17, 1992.

Attorney(s) appearing for the Case

Robert P. Reznick, Hughes, Hubbard & Reed, Washington, D.C., for Schering Corp.

Alvin J. Lorman, Akin, Gump, Hauer & Feld, Washington, D.C., for Copley.

R. Anthony Howard, King & Spaulding, Washington, D.C., for Agvar.

Heidi A. Garland, Jeffrey Chasnow, U.S. Dept. of Justice, Washington, D.C., for Louis W. Sullivan, et al.

MEMORANDUM OPINION

BOUDIN, District Judge.

The Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301-394, provides that generic drugs may be approved pursuant to an abbreviated application procedure. 21 U.S.C. § 355(j). To receive such approval an applicant must show, among other things, that the generic drug is "bioequivalent" to a previously approved drug.1 21 U.S.C. §§ 355(j)(2)(A)(iv), ...

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