Legal Opinion

IMS LTD. v. Califano

District Court, C.D. California

Decided November 28, 1977No. Civ. 77-2552-RJKPublishedCited by 6 opinions

1Opinion of the Court

MEMORANDUM OF DECISION AND ORDER

KELLEHER, District Judge.

Plaintiff filed a complaint on July 11, 1977, seeking a declaratory judgment that a certain drug (furosemide) is not a “new drug” within the meaning of §§ 201 and 505 of the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 321(p) and 355, so as to require plaintiff to file with and obtain approval of a new drug application (NDA) from the FDA. The complaint also seeks injunctive relief restraining the FDA from proceeding against plaintiff’s stocks of furosemide by way of libel and condemnation.

On June 13, 1977, the District Director for the Los…

2Cases cited4 opinions

  1. Weinberger v. Hynson, Westcott & Dunning, Inc.Supreme Court of the United States · 1973
  2. Weinberger v. Bentex Pharmaceuticals, Inc.Supreme Court of the United States · 1973
  3. Ciba Corp. v. WeinbergerSupreme Court of the United States · 1973
  4. The National Ethical Pharmaceutical Association v. WeinbergerCourt of Appeals for the Fourth Circuit · 1974

3Cited by6 opinions

  1. Biotics Research Corporation v. Margaret Heckler, Sec'y Etc., Seroyal Brands, Inc. v. Margaret Heckler, Sec'y Etc.Court of Appeals for the Ninth Circuit · 1983
  2. Dietary Supplemental Coalition, Inc. The Health Haus, Inc. v. Louis W. Sullivan, M.D. David A. Kessler, Commissioner of Food and Drug AdministrationCourt of Appeals for the Ninth Circuit · 1992
  3. Pharmadyne Laboratories, Inc. v. KennedyDistrict Court, D. New Jersey · 1979
  4. United States v. Desiree International U. S. A., Ltd.District Court, S.D. New York · 1980
  5. Center for Food Safety v. HamburgDistrict Court, N.D. California · 2015

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