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FDA APPROVES FIRST GENERIC WELLBUTRIN

December 15, 2006

The FDA has approved the first generic version of Wellbutrin XL (bupropion hydrochloride), which is indicated for the treatment of major depressive disorder. In 2005 Wellbutrin XL was the 21st highest-selling brand-name drug in the United States, with sales totaling roughly $1.3, according to the FDA.

The abbreviated new drug application (ANDA), for 150- and 300-mg doses, was submitted by Anchen Pharmaceuticals.

The brand drugmaker, Biovail, had asked a federal district court to block the FDA from approving any generic versions of Wellbutrin XL until after the agency resolves bioequivalence issues in a citizen petition filed by the drugmaker.

After reviewing the issues raised in the citizen petition, FDA determined that its standards for approval of the generic drug application for bupropion are appropriate.