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SCHERING CORP. v. SHALALA

No. 92-5103.

995 F.2d 1103 (1993)

SCHERING CORPORATION, Appellant, v. Donna E. SHALALA, Secretary, Health and Human Services; David A. Kessler, M.D., Commissioner of Food and Drugs; Agvar Chemicals Inc.; Copley Pharmaceutical Inc., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided June 15, 1993.

Attorney(s) appearing for the Case

Robert P. Reznick, Washington, DC, argued the cause and filed the brief for appellant.

Heidi A. Garland, Atty., Dept. of Justice, Washington, DC, argued the cause for the federal appellees. With her on the briefs were Stuart M. Gerson, Asst. Atty. Gen., Barbara C. Biddle, Asst. Director, Appellate Staff, and Jeffrey B. Chasnow, Atty., Dept. of Justice, Washington, DC.

R. Anthony Howard, Jr., Washington, DC, argued the cause for appellee Agvar Chemicals Inc. With him on the briefs were James D. Miller, Jess H. Stribling, Jr., and Kerrie C. Dent, Washington, DC.

Alvin J. Lorman, Washington, DC, argued the cause for appellee Copley Pharmaceutical Inc. With him on the briefs was Catherine J. McEnearney. W. Randolph Teslik, Washington, DC, also entered an appearance for appellee Copley Pharmaceutical Inc.

Before: SENTELLE, HENDERSON, and RANDOLPH, Circuit Judges.

PER CURIAM:

Schering Corporation brings this appeal from the district court's judgment sustaining the Food and Drug Administration's view, expressed in 1990 in response to a citizen petition, that the agency is not limited to determining "bioequivalence" by applying the test set forth in 21 U.S.C. § 355(j)(7)(B). 782 F.Supp. 645. In light of the FDA's promulgation in 1992 of regulations...

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