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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