Generic Drugs

FDA approves generic versions of Wellbutrin SR

Published in Medical Letter on the CDC and FDA, February 29th, 2004

IMPAX Laboratories, Inc., (IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the company's abbreviated new drug application for its generic version of Wellbutrin SR (Bupropion Hydrochloride) 100 mg controlled release tablets and has granted tentative approval to the company's generic version of Wellbutrin SR 150 mg controlled release tablets.

GlaxoSmithKline (GSK) markets Wellbutrin SR for the treatment of depression.

According to NDCHealth, U.S. sales of these dosage forms of Wellbutrin SR Tablets were approximately $1.6 billion in the 12 months ended November 30, 2003.

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Source: Medical Letter on the CDC and FDA (2004-02-29)

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