Legal Opinion

Astrazeneca Pharmaceuticals Lp v. Food and Drug Administration

District Court, District of Columbia

Decided July 5, 2012No. Civil Action No. 2012-0472PublishedCited by 12 opinions

1Opinion of the Court

AMENDED MEMORANDUM OPINION

BERYL A. HOWELL, District Judge.

Plaintiff AstraZeneca Pharmaceuticals LP (“AstraZeneca”) has manufactured the drug quetiapine fumarate (“quetiapine”) under the brand name Seroquel® (“Seroquel”) since 1997 without generic competition. AstraZeneca brought this lawsuit, which presents a question of statutory interpretation, against the Food and Drug Administration, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services (collectively, “the FDA”), to challenge the FDA’s approval, on March 27, 2012, of…

2Cases cited32 opinions

  1. Anderson v. Liberty Lobby, Inc.Supreme Court of the United States · 1986
  2. Celotex Corp. v. Catrett, Administratrix of the Estate of CatrettSupreme Court of the United States · 1986
  3. Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
  4. Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
  5. Burlington Truck Lines, Inc. v. United StatesSupreme Court of the United States · 1962

27 more not listed; retrieve them via the Exa API.

3Cited by12 opinions

  1. AstraZeneca Pharmaceuticals LP v. Food & Drug AdministrationCourt of Appeals for the D.C. Circuit · 2013
  2. Veloxis Pharmaceuticals, Inc. v. United States Food and Drug AdministrationDistrict Court, District of Columbia · 2015
  3. Viropharma Incorporated v. HamburgDistrict Court, District of Columbia · 2013
  4. Otsuka Pharm. Co. v. BurwellCourt of Appeals for the D.C. Circuit · 2016
  5. Braeburn Inc. v. U.S. Food & Drug Admin.Court of Appeals for the D.C. Circuit · 2019

7 more not listed; retrieve them via the Exa API.

Showing a preview — retrieve the full document via the Exa API.

Powered by the Exa API