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APOTEX, INC. v. SHALALA

No. Civ.A. 99-729(EGS).

53 F.Supp.2d 454 (1999)

APOTEX, INC., Plaintiff, v. Donna SHALALA, et al., Defendants.

United States District Court, District of Columbia.

June 16, 1999.

Attorney(s) appearing for the Case

John M. Murdock, Daly D.E. Temchine, Epstein, Becker & Green, Washington, DC, Terrence P. Canade, Lord, Bissell & Brook, Chicago, IL, for Apotex, Inc.

Drake Cutini, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, for Donna E. Shalala, Jane E. Henney, Food & Drug Admin.

David Weeda, Arthur Y. Tsien, John R. Fleder, Olsson, Frank & Weeda, Washington, DC, Robert F. Green, Leydig, Voit & Mayer, Chicago, IL, for NovoPharm Ltd.

MEMORANDUM OPINION AND ORDER

SULLIVAN, District Judge.

INTRODUCTION

Plaintiff Apotex, Inc., through its TorPharm division (hereinafter "TorPharm"), commenced this lawsuit to enjoin the Food and Drug Administration ("FDA") from granting a 180-day period of exclusivity to Novopharm Limited ("Novopharm") to market generic over-the-counter ("OTC") strength ranitidine hydrochloride. Plaintiff claims that the FDA has ignored a key provision...

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