Judge Blocks Approval of ANDA for Wellbutrin

Law360, New York (December 3, 2003, 12:00 AM EST) -- A Florida federal judge Wednesday granted generic drugmaker Andrx a temporary restraining order that prevents U.S. regulators from approving any generic form of GlaxoSmithKline's antridepressant Wellbutrin.

Andrx claims in the lawsuit that the FDA improperly granted approval of Eon's generic tablets.

The ruling by a magistrate judge for the United States District Court for the Southern District of Florida prevents the U.S. Food and Drug Administration from granting final approval of Eon Labs’ abbreviated new drug application (ANDA) for extended release Bupropion Hydrochloride, 100 mg tablets,...
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