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IMS LTD. v. CALIFANO

Civ. No. 77-2552-RJK.

453 F.Supp. 157 (1977)

IMS LIMITED, d/b/a International Medication Systems Ltd., a corporation of Delaware, Plaintiff, v. Joseph A. CALIFANO, Jr., Secretary of Health, Education and Welfare, and Donald Kennedy, Commissioner of the Food and Drug Administration, Defendants.

United States District Court, C. D. California.

November 28, 1977.

Attorney(s) appearing for the Case

Joseph E. Mueth, Wills, Green & Mueth Law Corp., Los Angeles, Cal., for plaintiff.

Dzintra I. Janavs, Asst. U. S. Atty., Los Angeles, Cal., for defendants.

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...

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