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MYLAN PHARMACEUTICALS, INC. v. SHALALA

No. Civ.A 99-2995 (RWR).

81 F.Supp.2d 30 (2000)

MYLAN PHARMACEUTICALS, INC., Plaintiff, v. Donna SHALALA, Secretary, U.S. Department of Health and Human Services, et al., Defendants.

United States District Court, District of Columbia.

January 4, 2000.

Attorney(s) appearing for the Case

E. Anthony Figg, Joseph Anthony Hynds, Rothwell, Figg, Ernst & Kurz, Washington, DC, for Mylan Pharmaceuticals.

Kevin Clark Maclay, Jones, Day, Reavis & Pogue, Washington, DC, Daniel E. Reidy, James A. White, Timothy J. Heverin, Jones, Day, Reavis & Pogue, Chicago, IL, for defendant-intervenor Abbott Labatories.

Martha Jennet Talley, Dewey Ballantine, LLP, Washington, DC, Wayne A. Cross, Robert A. Milne, Eamon O'Kelly, Dewey Ballantine LLP, New York City, for defendant-intervenor Geneva.

Drake Stephen Cutini, Andrew E. Clark, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, for defendant.

MEMORANDUM OPINION

ROBERTS, District Judge.

This suit challenges the validity of a Food and Drug Administration ("FDA") regulation governing the approval process for generic drugs. Plaintiff Mylan Pharmaceuticals, Inc. ("Mylan"), a generic drug manufacturer, alleges that pursuant to the regulation, the FDA has unlawfully refused to approve Mylan's application to market a generic version of a brand-name drug. Mylan sues for a declaratory judgment invalidating...

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