BIOVAIL SEEKS TO RESTRICT APPROVALS OF GENERIC WELLBUTRIN XL

Biovail has asked a federal district court to block the FDA from approving any generic versions of its extended-release antidepressant, Wellbutrin XL, until after the agency resolves bioequivalence issues in a citizen petition filed by the drugmaker.

The drugmaker announced Aug. 24 that it has filed a suit in the U.S. District Court for the District of Columbia seeking a temporary restraining order and a preliminary injunction forcing the FDA to resolve issues raised in Biovail's petition at least one week before approving any generic versions of Wellbutrin XL (bupropion HCl extended-release tablets). The company wants to ensure it can sue the agency if it does not take into account the approval criteria set forth by Biovail.

Biovail's petition, filed last December, urges the FDA to require "rigorous bioequivalence testing" for proposed generic versions of Wellbutrin XL.

Sales of Wellbutrin XL were $179 million in the first half of 2006, compared with $107 million in the first half of 2005, according to Biovail.