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SOMERSET PHARMACEUTICALS, INC. v. SHALALA

C.A. No. 96-403-SLR.

973 F.Supp. 443 (1997)

SOMERSET PHARMACEUTICALS, INC., Plaintiff, v. Donna SHALALA, in her official capacity as Secretary of Health and Human Services; and Dr. David Kessler, in his official capacity as Commissioner of the Food and Drug Administration, Defendants.

United States District Court, D. Delaware.

June 13, 1997.

Attorney(s) appearing for the Case

Lawrence S. Drexler of Oberly, Jennings & Drexler, P.A., Wilmington, DE, for plaintiff; Stephen C. Page, Sheila D. Biehl and Patricia A. Leonard of Gunster, Yoakley, Valdes-Fauli & Stewart, P.A., Stuart, FL, of counsel.

Frank W. Hunger, Assistant Attorney General, Civil Division, Gregory M. Sleet, United States Attorney, Patricia C. Hannigan, Assistant United States Attorney, and Gerald C. Kell, Senior Trial Counsel, Office of Consumer Litigation, United States Department of Justice, for defendant; Margaret Jane Porter, Chief Counsel, Neal Parker, Associate Chief Counsel, and Elizabeth Dickinson, Assistant Chief Counsel, Food and Drug Administration, Rockville, MD, of counsel.

MEMORANDUM OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

On August 5, 1996, plaintiff Somerset Pharmaceuticals, Inc. filed a verified complaint for injunctive and declaratory relief and review of agency action, asserting jurisdiction under 28 U.S.C. §§ 1331 and 1361. (D.I.1) Also filed were motions for the issuance of a temporary restraining order and a preliminary injunction, with supporting documentation. (D.I.2-7) Limited...

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