Legal Opinion
Warner-Lambert Co. v. Heckler
Court of Appeals for the Third Circuit
Decided April 1, 1986No. Nos. 85-3371, 85-3377 and 85-3383PublishedCited by 8 opinions
1Opinion of the Court
OPINION OF THE COURT
SLOVITER, Circuit Judge.
Several novel issues regarding the required showing of efficacy of new drugs are presented in this appeal by four drug manufacturers from the Order of the Commissioner of the Food and Drug Administration (FDA) withdrawing approval for the oral proteolytic enzymes (OPEs) that they manufacture. The Commissioner withdrew *149approval of the new drug applications for these drugs after concluding that there was a lack of substantial evidence that the OPEs will have the effects they are purported or represented to have for their intended conditions of use.…
2Cases cited18 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Daniel P. Cotter v. Patricia Roberts Harris, Secretary of Health and Human ServicesCourt of Appeals for the Third Circuit · 1981
- Weinberger v. Hynson, Westcott & Dunning, Inc.Supreme Court of the United States · 1973
- United States v. RutherfordSupreme Court of the United States · 1979
- United States v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., Pfizer, Inc., Claimant-AppellantCourt of Appeals for the Fifth Circuit · 1984
13 more not listed; retrieve them via the Exa API.
3Cited by8 opinions
- 36 Fed. R. Evid. Serv. 1338, prod.liab.rep. (Cch) P 13,478 Kathy D. Tobin, (91-6413), (91-6478) v. Astra Pharmaceutical Products, Inc., (91-6413), Duphar B v. (91-6478)Court of Appeals for the Sixth Circuit · 1993
- Tobin v. Astra Pharmaceutical Products, Inc.Court of Appeals for the Sixth Circuit · 1993
- United States v. 225 Cartons, More Or Less, Of An Article Or DrugCourt of Appeals for the Third Circuit · 1989
- United States v. 225 Cartons, More or Less, of an Article or DrugCourt of Appeals for the Third Circuit · 1989
- David Stanley Consultants v. Director Office of Workers ComCourt of Appeals for the Third Circuit · 2020
3 more not listed; retrieve them via the Exa API.