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NORTH AMERICAN PHARMACAL, INC. v. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

Nos. 73-1252, 73-1386.

491 F.2d 546 (1973)

NORTH AMERICAN PHARMACAL, INC., etc., et al., Petitioners, v. The DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, etc., Respondent. COASTAL PHARMACEUTICAL CO., INC., Petitioner, v. FOOD AND DRUG ADMINISTRATION, Respondent.

United States Court of Appeals, Eighth Circuit.

Decided December 28, 1973.

Attorney(s) appearing for the Case

Richard L. White, McLean, Va., for petitioners.

Howard S. Epstein, Atty., Consumer Affairs Section, Dept. of Justice, Washington, D. C., for respondents.

Before GIBSON, Circuit Judge, MOORE, Senior Circuit Judge, and WEBSTER, Circuit Judge.

GIBSON, Circuit Judge.

Petitioners, manufacturers of anorectic drugs1 containing amphetamines, in this original action ask for injunctive relief and to set aside an order of the Food and Drug Administration (FDA) withdrawing approval of all New-Drug Applications (NDA's) covering combination amphetamine products. Jurisdiction in this court is predicated upon 21 U.S.C. § 355(h) which provides...

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