Sanofi-Aventis U.S. LLC v. Food and Drug Administration
District Court, District of Columbia
1Opinion of the Court
MEMORANDUM OPINION
AMY BERMAN JACKSON, District Judge.
Plaintiff Sanofi-Aventis U.S. LLC (“Sanofi”) brought this action against the Food and Drug Administration (“FDA”), its Commissioner of Food and Drugs, Margaret A. Hamburg, and the Secretary of Health and Human Services, Kathleen Sebelius, alleging that FDA exceeded its statutory authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and unlawfully departed from agency precedent when it approved a generic version of the Sanofi drug Lovenox. Sandoz, Inc. (“Sandoz”), the manufacturer of the generic drug, intervened as a defendant,…
2Cases cited23 opinions
- Anderson v. Liberty Lobby, Inc.Supreme Court of the United States · 1986
- Celotex Corp. v. Catrett, Administratrix of the Estate of CatrettSupreme Court of the United States · 1986
- 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
- Pilot Life Insurance v. DedeauxSupreme Court of the United States · 1987
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