ZENECA, INC. v. SHALALA

No. 99-2329.

213 F.3d 161 (2000)

ZENECA, INCORPORATED, Plaintiff-Appellant, v. Donna E. SHALALA, in her official capacity as Secretary of Health and Human Services; Jane Henney, M.D., Commissioner of the Food and Drug Administration, Defendant-Appellees, v. Gensia Sicor Pharmaceuticals, Incorporated, Movant-Appellee.

United States Court of Appeals, Fourth Circuit.

Decided: May 17, 2000.


Attorney(s) appearing for the Case

ARGUED: Anthony Craig Roth, Morgan, Lewis & Bockius, L.L.P., Washington, D.C., for Appellant. Gerald Cooper Kell, Senior Trial, Office of Consumer Litigation, United States Department of Justice, Washington, D.C., for Appellees Shalala and Henney; David Glenn Adams, Venable, Baetjer, Howard & Civiletti, L.L.P., Washington, D.C., for Appellee Gensia Sicor. ON BRIEF: Stephen P. Mahinka, Morgan, Lewis & Bockius, L.L.P., Washington, D.C., for Appellant. David W. Ogden, Acting Assistant Attorney General, Office of Consumer Litigation, United States Department of Justice, Washington, D.C.; Barbara J. Stradling, Associate Chief for Enforcement, Food And Drug Administration, Washington, D.C., for Appellees Shalala and Henney. James N. Czaban, Venable, Baetjer, Howard & Civiletti, L.L.P., Washington, D.C., for Appellee Gensia Sicor.

Before NIEMEYER, Circuit Judge, HAMILTON, Senior Circuit Judge, and MINER, Senior Circuit Judge of the United States Court of Appeals for the Second Circuit, sitting by designation.


Affirmed by published opinion. Senior Judge HAMILTON wrote the opinion, in which Judge NIEMEYER and Senior Judge MINER joined.

OPINION

HAMILTON, Senior Circuit Judge.

This case involves a challenge by appellant Zeneca, Inc. (Zeneca), the manufacturer of the prescription drug DIPRIVAN, to the Food and Drug Administration's (the FDA) approval of a generic version of DIPRIVAN manufactured by intervenor-appellee Gensia Sicor Pharmaceuticals, Inc. (Gensia...

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