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VIROPHARMA, INC. v. HAMBURG

Civil Action No. 10-1529 (ESH).

777 F.Supp.2d 140 (2011)

VIROPHARMA, INCORPORATED, Plaintiff, v. Margaret A. HAMBURG, M.D., in her official capacity as Commissioner, Food and Drug Administration, et al., Defendants.

United States District Court, District of Columbia.

April 15, 2011.

Attorney(s) appearing for the Case

Fahad A. Habib , Rosanna K. McCalips , Thomas F. Cullen , Jones Day, Washington, DC, for Plaintiff.

Andrew E. Clark , U.S. Department of Justice, Office of Consumer Litigation, James Philip Ellison , Hyman, Phelps & McNamara, P.C., Washington, DC, for Defendants.

MEMORANDUM OPINION

ELLEN SEGAL HUVELLE, District Judge.

Plaintiff ViroPharma Incorporated ("ViroPharma") brings this action against the Food and Drug Administration ("FDA") and the Department of Health and Human Services, seeking review under the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 701-706. Specifically, ViroPharma claims that that FDA failed to conduct notice-and-comment rulemaking prior to what plaintiff claims was a decision...

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