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Dec. 15, 2006 -- The FDA has approved the first generic version of the antidepressant Wellbutrin XL (bupropion).
In 2005, Wellbutrin XL -- the latest version of Wellbutrin -- was the 21st highest-selling brand-name drug in the U.S, with sales totaling more than $1.3 million, according to the online magazine Drug Topics, the FDA notes.
The benefit to consumers of FDA's generic drug approval is significant because generic drug products, which are used to fill more than 50% of all prescriptions, often cost a fraction of the price of the brand-name drug.
"Bupropion hydrochloride is a widely-used antidepressant, and its generic version can bring significant savings to the millions of Americans with depressiondepression," says Gary J. Buehler, RPh, who directs the FDA's Office of Generic Drugs.
"This approval is another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits," says Buehler in an FDA news release.
The FDA assures consumers and health professionals that an approved generic drug is as safe and effective as a brand-name drug.
The same thorough and rigorously scientific review standards of safety, efficacy, and quality are applied to generic drugs as are applied to brand drugs, according to the FDA.
Generic bupropion extended-release tablets will be sold in two doses: 150 milligrams and 300 milligrams.
The generic tablets are made by Anchen Pharmaceuticals of Irvine, Calif.
Wellbutrin XL is made by GlaxoSmithKline, a WebMD sponsor.
SOURCE: News release, FDA.