STERLING DRUG, INC. v. WEINBERGER

No. 549, Docket 74-2477.

509 F.2d 1236 (1975)

STERLING DRUG, INC. et al., Plaintiff-Appellants, v. Caspar W. WEINBERGER, Secretary of Health, Education and Welfare, and Alexander M. Schmidt, Commissioner of Food and Drugs, Defendants-Appellees.

United States Court of Appeals, Second Circuit.

Decided January 7, 1975.


Attorney(s) appearing for the Case

William F. Weigel, New York City (Rogers, Hoge & Hills, James B. Swire, E. Carrington Boggan, James H. Luther, Jr., and Roger M. Rodwin, New York City, of counsel), for plaintiffs-appellants.

Jerry L. Siegel, Asst. U. S. Atty. (Paul J. Curran, U. S. Atty., S. D. N. Y., and Gerald A. Rosenberg, Asst. U. S. Atty., of counsel), for defendants-appellees.

Before FRIENDLY, TIMBERS and GURFEIN, Circuit Judges.


FRIENDLY, Circuit Judge:

Six and a half years after the Food and Drug Administration began its bumbling efforts to withdraw approval of the New Drug Application (NDA) for Alevaire, an aerosol prescription drug administered to patients with chronic respiratory diseases, on the ground of lack of substantial evidence that it will have the effect it is represented to have under the conditions of use set out in its labeling, the case is back again — only a few months...

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