UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT
October 9, 1974
STERLING DRUG INC., WINTHROP PRODUCTS, INC. AND BREON LABORATORIES, INC., PETITIONERS,
CASPAR W. WEINBERGER, SECRETARY OF HEALTH, EDUCATION AND WELFARE, AND ALEXANDER M. SCHMIDT, COMMISSIONER OF FOOD AND DRUGS, RESPONDENTS
503 F.2d 675.
Mulligan and Waterman, Circuit Judges, and Bryan, District Judge.
Author: Per Curiam
Petitioners have moved for an order directing respondents (1) to publish notice of reinstatement of approval of the New Drug Applications for Alevaire in the Federal Register and (2) to remove a listing of Alevaire as "ineffective" from the "FDA Interim Index To Evaluations Published In The Federal Register For NAS-NRC Reviewed Drugs."
Since the motion was made, the FDA has issued and published in the Federal Register a new "Notice of Opportunity for Hearing" on a proposal withdrawing approval of New Drug Applications for Alevaire, as it was permitted to do by our decision of May 2, 1974. The notice makes specific reference to that decision. The first branch of petitioners' motion is denied.
The nature of the FDA Interim Index and the basis on which listings thereon are made were not before us and were not explored on the appeal. We did not pass on the propriety of the listing of Alevaire on that Index, either in footnote 14 of the opinion or otherwise. The second branch of petitioner's motion is denied without prejudice to such other remedies as may be available to the petitioners.
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