Legal Opinion
Hi-Tech Pharmacal Co. v. United States Food & Drug Administration
District Court, District of Columbia
Decided December 10, 2008No. Civil Action 08-01495 (JDB)PublishedCited by 19 opinions
1Opinion of the Court
MEMORANDUM OPINION
JOHN D. BATES, District Judge.
On October 28, 2008, defendant Food and Drug Administration (“FDA”) issued a final letter decision in which it determined that plaintiff Hi-Tech Pharmacal Co., Inc. (“Hi-Tech”) had forfeited its 180-day period of marketing exclusivity under the Federal Food, Drug, and Cosmetic Act for the generic version of the branded drug CO-SOPT. Currently before the Court is Hi-Tech’s motion for a preliminary injunction, permanent injunction, and declaratory judgment seeking to vacate FDA’s decision under the Administrative Procedure Act (“APA”) as…
2Cases cited16 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Citizens to Preserve Overton Park, Inc. v. VolpeSupreme Court of the United States · 1971
- Trudeau v. Federal Trade CommissionCourt of Appeals for the D.C. Circuit · 2006
- Pauley v. BethEnergy Mines, Inc.Supreme Court of the United States · 1991
- Demarest v. ManspeakerSupreme Court of the United States · 1991
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3Cited by19 opinions
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- Veloxis Pharmaceuticals, Inc. v. United States Food and Drug AdministrationDistrict Court, District of Columbia · 2015
- Otay Mesa Property, L.P. v. United States Department of the InteriorDistrict Court, District of Columbia · 2015
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