Biovail Corp. v. U.S. Food & Drug Administration
District Court, District of Columbia
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…
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- Califano v. SandersSupreme Court of the United States · 1977
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