Legal Opinion
Schering Corp. v. Sullivan
District Court, District of Columbia
Decided January 17, 1992No. Civ. A. 90-1804(MB)PublishedCited by 9 opinions
1Opinion of the Court
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®. 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®(2)(A)(iv), ®(3)(F). The FDCA further provides that a new drug “shall be considered to be bioequivalent to a listed [i.e., previously approved] drug” if the rate and extent of absorption of the new drug do not…
2Cases cited9 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Russello v. United StatesSupreme Court of the United States · 1983
- Washington Metropolitan Area Transit Commission v. Holiday Tours, Inc.Court of Appeals for the D.C. Circuit · 1977
- Weinberger v. Hynson, Westcott & Dunning, Inc.Supreme Court of the United States · 1973
- Mead Johnson Pharmaceutical Group, Mead Johnson & Company v. Otis R. Bowen, Secretary of H.H.S.Court of Appeals for the D.C. Circuit · 1988
4 more not listed; retrieve them via the Exa API.
3Cited by9 opinions
- Schering Corporation v. Food and Drug AdministrationCourt of Appeals for the Third Circuit · 1995
- Bristol-Myers Squibb Co. v. ShalalaDistrict Court, District of Columbia · 1996
- Schering Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1993
- Biovail Corp. v. U.S. Food & Drug AdministrationDistrict Court, District of Columbia · 2006
- Apotex Inc. v. U.S. Food & Drug AdministrationDistrict Court, District of Columbia · 2007
4 more not listed; retrieve them via the Exa API.