Legal Opinion
Premo Pharmaceutical Laboratories, Inc. v. United States
District Court, S.D. New York
Decided July 27, 1979No. 78 Civ. 5435(MP)PublishedCited by 5 opinions
1Opinion of the Court
OPINION
POLLACK, District Judge.
This is a suit by a manufacturer of pharmaceutical drugs against the Secretary of Health, Education and Welfare and the Commissioner of Food and Drugs, seeking a declaratory judgment that a questioned product manufactured by the plaintiff is not classifiable as a new drug and therefore may be freely sold and distributed without prior approval by the Food and Drug Administration (“FDA” hereafter). The FDA has initiated seizure actions against the product in four states and has threatened to seize it elsewhere. Thus there exists a justiciable controversy between…
2Cases cited7 opinions
- Weinberger v. Hynson, Westcott & Dunning, Inc.Supreme Court of the United States · 1973
- The United States of America v. An Article of Drug . . . "Entrol-C Medicated", Naremco, Inc., Claimant-AppellantCourt of Appeals for the Ninth Circuit · 1975
- United States v. Articles of Drug, Etc. Appeal of the Lannett Company, IncCourt of Appeals for the Third Circuit · 1978
- United States v. X-Otag Plus TabletsDistrict Court, D. Colorado · 1977
- Pharmadyne Laboratories, Inc. v. KennedyCourt of Appeals for the Third Circuit · 1979
2 more not listed; retrieve them via the Exa API.
3Cited by5 opinions
- Premo Pharmaceutical Laboratories, Inc. v. United StatesCourt of Appeals for the Second Circuit · 1980
- United States v. Premo Pharmaceutical Laboratories, Inc.District Court, D. New Jersey · 1981
- United States v. Generix Drug Corporation, a Corporation, Lewis Michael Orlove, Gary R. Dubin, and Ofelia Perez, IndividualCourt of Appeals for the Fifth Circuit · 1981
- United States v. Generix Drug Corp.District Court, S.D. Florida · 1980
- Premo Pharmaceutical Laboratories, Inc. v. United StatesCourt of Appeals for the Second Circuit · 1980