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MYLAN PHARMACEUTICALS INC. v. HENNEY

Civil Action Nos. 99-cv-862(RMU), 99-cv-801 (RMU).

94 F.Supp.2d 36 (2000)

MYLAN PHARMACEUTICALS INC., Plaintiff, v. Jane E. HENNEY and Donna E. Shalala, Defendants, Barr Laboratories, Inc., Intervenor-Defendant. Pharmachemie B.V., Plaintiff, v. Jane E. Henney and Donna E. Shalala, Defendants, Barr Laboratories, Inc., Intervenor-Defendant.

United States District Court, District of Columbia.

March 31, 2000.

Attorney(s) appearing for the Case

James Harold Wallace, Jr., Wiley, Rein & Fielding, Washington, DC, for Mylan Pharmaceuticals, Inc.

Mark E. Nagle, Wilma Antoinette Lewis, Meredith Manning, U.S. Attorney's Office, Washington, DC, for Jane E. Henney, Donna E. Shalala.

Michael K. Atkinson, Charles Bennett Klein, Winston & Strawn, Washington, DC, for Barr Laboratories, Inc.

Geoffrey M. Levitt, James N. Czaban, Venable, Baetjer, Howard & Civiletti, L.L.P., Washington, DC, for Pharmachemie B.V.

MEMORANDUM OPINION

URBINA, District Judge.

ORDERING CONSOLIDATION OF CASES; DENYING MYLAN'S AND PHARMACHEMIE'S MOTIONS FOR INJUNCTIVE RELIEF; DENYING MYLAN'S AND PHARMACHEMIE'S MOTIONS TO INTERVENE; REMANDING TO FDA FOR PERMISSIBLE INTERPRETATION OF 21 U.S.C. § 355(j)(5)(B)(iv) AND REGULATION 314.94(a)(12)(viii)

I. INTRODUCTION

Pharmachemie, B.V. ("Pharmachemie") and Mylan Pharmaceuticals, Inc. ("Mylan"), generic manufacturers...

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