Legal Opinion

Biovail Corp. v. U.S. Food & Drug Administration

District Court, District of Columbia

Decided September 6, 2006No. Civil Action 06-1487 (RMU)PublishedCited by 19 opinions

1Opinion of the Court

MEMORANDUM OPINION

Denying the Plaintiffs’ Motion for a Temporary Restraining Order

URBINA, District Judge.

I. INTRODUCTION

The plaintiffs, Biovail Corporation and Biovail Laboratories International SRL (collectively, “the plaintiff’ or “Biovail”) manufacture the drug Wellbutrin XL. De-fendanWIntervenor Anchen Pharmaceuticals, Inc. (“Anchen”) is awaiting defendant Food & Drug Administration’s (“FDA”) 1 approval of its generic version of Wellbut-rin XL. In December 2005, Biovail filed a citizen petition 2 with the defendant to raise Biovail’s concerns regarding.the defendant’s evaluation of…

2Cases cited33 opinions

  1. Mathews v. EldridgeSupreme Court of the United States · 1976
  2. Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
  3. Citizens to Preserve Overton Park, Inc. v. VolpeSupreme Court of the United States · 1971
  4. Paul v. DavisSupreme Court of the United States · 1976
  5. Califano v. SandersSupreme Court of the United States · 1977

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3Cited by19 opinions

  1. Hi-Tech Pharmacal Co. v. United States Food & Drug AdministrationDistrict Court, District of Columbia · 2008
  2. Viropharma Incorporated v. HamburgDistrict Court, District of Columbia · 2012
  3. Citizens for Responsibility & Ethics in Wash. v. U.S. Dep't of Homeland Sec.Court of Appeals for the D.C. Circuit · 2019
  4. Astrazeneca Pharmaceuticals Lp v. Food and Drug AdministrationDistrict Court, District of Columbia · 2012
  5. Hill Dermaceuticals, Inc. v. U.S. Food & Drug AdministrationDistrict Court, District of Columbia · 2007

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