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HILL DERMACEUTICALS, INC. v. FOOD & DRUG ADMIN.

No. 12-5182.

709 F.3d 44 (2013)

HILL DERMACEUTICALS, INC., Appellant v. FOOD & DRUG ADMINISTRATION, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided March 12, 2013.

Attorney(s) appearing for the Case

Larry M. Roth argued the cause for appellant. With him on the brief was Neil P. Di Spirito .

Cindy J. Cho , Attorney, U.S. Department of Justice, argued the cause for appellees. With her on the brief were Stuart F. Delery , Principal Deputy Assistant Attorney General, Maame Ewusi-Mensah Frimpong , Deputy Assistant Attorney General, and Drake Cutini , Attorney.

William D. Coston , Martin L. Saad , and David D. Conway were on the brief for intervenor Amneal Pharmaceuticals, LLC in support of appellee.

Opinion for the Court filed PER CURIAM.

PER CURIAM:

Hill Dermaceuticals filed a successful new drug application with the FDA in 1988 for a corticosteroid called "Derma-Smoothe." The application included three separate products — body oil, scalp oil, and ear oil drops. In 2011 the FDA approved three abbreviated new drug applications ("ANDAs") submitted by Identi Pharmaceuticals for generic versions of Hill's three products. Hill sued the FDA in the U.S. District Court for the District of Columbia...

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