Legal Opinion
Mylan Pharmaceuticals, Inc. v. Shalala
District Court, District of Columbia
Decided January 4, 2000No. Civ.A 99-2995 (RWR)PublishedCited by 89 opinions
1Opinion of the Court
MEMORANDUM OPINION
ROBERTS, District Judge.
This suit challenges the validity of a Food and Drug Administration (“FDA”) regulation governing the approval process for generic drugs. Plaintiff Mylan Pharmaceuticals, Inc. (“Mylan”), a generic drug manufacturer, alleges that pursuant to the regulation, the FDA has unlawfully refused to approve Mylan’s application to market a generic version of a brand-name drug. Mylan sues for a declaratory judgment invalidating the regulation, and preliminary and permanent injunctions ordering the FDA to grant immediate and final approval of Mylan’s application.…
2Cases cited35 opinions
- Anderson v. Liberty Lobby, Inc.Supreme Court of the United States · 1986
- Lujan v. Defenders of WildlifeSupreme Court of the United States · 1992
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- United States v. Ron Pair Enterprises, Inc.Supreme Court of the United States · 1989
- Amoco Production Co. v. Village of GambellSupreme Court of the United States · 1987
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3Cited by89 opinions
- Meijer, Inc. v. Biovail Corp.Court of Appeals for the D.C. Circuit · 2008
- National Mining Ass'n v. JacksonDistrict Court, District of Columbia · 2011
- In Re Cardizem CD Antitrust LitigationDistrict Court, E.D. Michigan · 2000
- Mylan Inc. v. Smithkline Beecham Corp.Court of Appeals for the Third Circuit · 2013
- Valley Drug Company v. Geneva Pharmaceuticals, Inc.Court of Appeals for the Eleventh Circuit · 2003
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