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AMNEAL PHARMACEUTICALS LLC v. FOOD AND DRUG ADMIN.

Civil Action No. 17-18(RDM).

285 F.Supp.3d 328 (2018)

AMNEAL PHARMACEUTICALS LLC, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants, and Lupin Pharmaceuticals, Inc., et al., Intervenor-Defendants.

United States District Court, District of Columbia.

Filed January 24, 2018.

Editors Note
Applicable Law: 05 U.S.C. § 0706
Cause: 05 U.S.C. § 0706 Judicial Review of Agency Actions
Nature of Suit: 899 Administrative Procedure Act / Review or Appeal of Agency Decision
Source: PACER

Attorney(s) appearing for the Case

Dean Richlin, Pro Hac Vice, Marco J. Quina, Pro Hac Vice, Foley Hoag, LLP, Boston, MA, Areta L. Kupchyk, Foley Hoag LLP, Washington, DC, for Plaintiff.

James William Harlow, Kathleen M. Konopka, U.S. Department of Justice, Washington, DC, for Defendant.

William M. Jay, Brian Burgess, Joshua James Bone, Prescott Moore Lassman, Sarah K. Frederick, Goodwin Procter, LLP, Janine A. Carlan, Richard Jason Berman, Taniel Ermano Anderson, Arent Fox, LLP, Washington, DC, for Intervenor-Defendant.

MEMORANDUM OPINION

The Federal Food, Drug, and Cosmetic Act ("FDCA"), as amended by the Drug Price Competition and Patent Restoration Act of 1984 ("Hatch-Waxman Act") and the Medicare Prescription Drug Improvement and Modernization Act of 2003 ("Medicare Modernization...

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