Wellbutrin XL Goes Generic
Generic Version of Popular Antidepressant Equivalent to Brand, FDA Says
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
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
depression," 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.