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GRACEWAY PHARMACEUTICALS, INC. v. SEBELIUS

Civil Action No. 10-1154(RBW).

783 F.Supp.2d 104 (2011)

GRACEWAY PHARMACEUTICALS, LLC, Plaintiff, v. Kathleen SEBELIUS, Secretary, Department of Health and Human Services, et al., Defendants, and Nycomed US, Inc., Defendant-Intervenor.

United States District Court, District of Columbia.

May 10, 2011.

Attorney(s) appearing for the Case

Jonathan Abram, Susan Margaret Cook, Hogan Lovells U.S. LLP, Washington, DC, for Plaintiff.

Andrew E. Clark, U.S. Department of Justice Office of Consumer Litigation, Washington, DC, for Defendants.

Lawrence S. Sher, Andrew C. Bernasconi, Reed Smith LLP, Washington, DC, for Defendant-Intervenor.

MEMORANDUM OPINION

REGGIE B. WALTON, District Judge.

The plaintiff filed its Complaint in this case on July 8, 2010, alleging that certain actions taken by the United States Food and Drug Administration (the "FDA") violated both the Administrative Procedure Act ("APA"), 5 U.S.C. § 702 (2006), and the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 355(a) (2006). This case is now before the Court on the parties' cross-motions for summary...

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