Legal Opinion
Amgen Inc. v. Azar
Court of Appeals for the D.C. Circuit
Decided February 17, 2018No. Civil Action No. 17–1006 (RDM)PublishedCited by 1 opinion
1Opinion of the Court
RANDOLPH D. MOSS, United States District Judge
Amgen brought this action to challenge the decision of the Food and Drug Administration ("FDA") denying Amgen pediatric exclusivity for its drug, Sensipar (cinacalcet hydrochloride). In an earlier opinion and order, the Court granted the FDA summary judgment on all but one of Amgen's claims: its claim that the agency's denial of pediatric exclusivity for Sensipar was inconsistent with its decision to grant pediatric exclusivity for Johnson & Johnson's drug Ortho Tri-Cyclen. Amgen Inc. v. Hargan , 285 F.Supp.3d 351, 2018 WL 581006 (D.D.C. Jan. 26,…
2Cases cited7 opinions
- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
- Marsh v. Oregon Natural Resources CouncilSupreme Court of the United States · 1989
- Alaska Department of Environmental Conservation v. Environmental Protection AgencySupreme Court of the United States · 2004
- Advocates for Highway & Auto Safety v. Federal Motor Carrier Safety AdministrationCourt of Appeals for the D.C. Circuit · 2005
- Regents of the University of California v. BurwellDistrict Court, District of Columbia · 2016
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3Cited by1 opinion
- Friends of Animals v. U.S. Bureau of Land ManagementDistrict Court, District of Columbia · 2021