Legal Opinion
Amgen Inc. v. Hargan
Court of Appeals for the D.C. Circuit
Decided January 26, 2018No. Civil Action No. 17–1006 (RDM)PublishedCited by 5 opinions
1Opinion of the Court
RANDOLPH D. MOSS, United States District Judge
To encourage pharmaceutical companies to study the safety and effectiveness of pediatric uses of drugs approved for adults, the Federal Food, Drug, and Cosmetic Act ("FFDCA") grants six months of "pediatric exclusivity" to the sponsor of a brand-name drug if the sponsor conducts studies that "fairly respond" to a "written request" from the Food and Drug Administration ("FDA"). 21 U.S.C. § 355a(d)(4). At the urging of Plaintiff Amgen Inc., the FDA issued a written request asking that Amgen conduct pediatric studies of its drug Sensipar (cinacalcet…
2Cases cited61 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
- Citizens to Preserve Overton Park, Inc. v. VolpeSupreme Court of the United States · 1971
- United States v. Mead Corp.Supreme Court of the United States · 2001
- Marsh v. Oregon Natural Resources CouncilSupreme Court of the United States · 1989
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3Cited by5 opinions
- Sierra Club v. WheelerCourt of Appeals for the D.C. Circuit · 2018
- Amgen Inc. v. AzarCourt of Appeals for the D.C. Circuit · 2018
- Sierra Club v. McCarthyDistrict Court, District of Columbia · 2018
- St. Mary Medical Center v. Alex M. AzarDistrict Court, District of Columbia · 2022
- Vanda Pharmaceuticals, Inc. v. Food and Drug AdministrationDistrict Court, District of Columbia · 2025