Legal Opinion
Astellas Pharma US, Inc. v. Food & Drug Administration
District Court, District of Columbia
Decided August 12, 2009No. Civil Action 09-1511 (RMU)PublishedCited by 12 opinions
1Opinion of the Court
MEMORANDUM OPINION
Denying the Plaintiff’s Motion for a Temporary Restraining Order and Preliminary Injunction
RICARDO M. URBINA, District Judge'
1. INTRODUCTION
This matter is before the court on the plaintiffs motion for a temporary restraining order and preliminary injunction requiring the Food and Drug Administration (“FDA”) to withdraw its approval of any generic version of the immunosuppressant tacrolimus. The plaintiff, which pioneered the development of tacrolimus and markets it under the brand name Prograf®, contends that the FDA acted in an arbitrary and capricious manner in approving a…
2Cases cited32 opinions
- Winter v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 2008
- 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
- City of Los Angeles v. LyonsSupreme Court of the United States · 1983
- Califano v. SandersSupreme Court of the United States · 1977
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3Cited by12 opinions
- Viropharma Incorporated v. HamburgDistrict Court, District of Columbia · 2012
- Sanofi-Aventis U.S. LLC v. Food & Drug AdministrationDistrict Court, District of Columbia · 2010
- Cumberland Pharmaceuticals Inc. v. Food and Drug AdministrationDistrict Court, District of Columbia · 2013
- GRACEWAY PHARMACEUTICALS, INC. v. SebeliusDistrict Court, District of Columbia · 2011
- Lannett Co. v. U.S. Food & Drug Admin.Court of Appeals for the D.C. Circuit · 2017
7 more not listed; retrieve them via the Exa API.