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SERONO LABORATORIES, INC. v. SHALALA

Nos. 97-5188, 97-5227.

158 F.3d 1313 (1998)

SERONO LABORATORIES, INC., Appellee, v. Donna E. SHALALA, et al., and Ferring Pharmaceuticals Inc., Appellants.

United States Court of Appeals, District of Columbia Circuit.

Decided October 27, 1998.

Attorney(s) appearing for the Case

Christine N. Kohl, Attorney, U.S. Department of Justice, argued the cause for the federal appellants, with whom Frank W. Hunger, Assistant Attorney General, Mary Lou Leary, U.S. Attorney, and Douglas N. Letter, Litigation Counsel, U.S. Department of Justice, were on the briefs.

John R. Fleder, David F. Weeda and Arthur Y. Tsien were on the briefs for appellant Ferring Pharmaceuticals Inc.

Bruce S. Manheim, Jr. argued the cause for appellee, with whom Terry S. Coleman and Matthew D. Peterson were on the brief. Michael D. Petty entered an appearance.

Before: HENDERSON, ROGERS and GARLAND, Circuit Judges.

GARLAND, Circuit Judge:

In this case we consider the validity of a district court order, preliminarily enjoining approval by the Food and Drug Administration ("FDA") of a generic drug, that was issued at the behest of the manufacturer of the competing brand-name drug. We previously stayed the preliminary injunction pending our resolution of this appeal. Because we find plaintiff has not satisfied the standards for a preliminary injunction, and in particular has not...

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