FDA Approves Generic Extended-Release Wellbutrin
Drug is indicated for treatment of major depression
FRIDAY, Dec. 15 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first generic version of Wellbutrin XL Extended-Release Tablets for the treatment of major depressive disorder.
The bupropion hydrochloride extended-release tablets are available in 150 mg and 300 mg doses from Anchen Pharmaceuticals Inc., of Irvine, Calif.
"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," said Gary J. Buehler, R.Ph., director of the Office of Generic Drugs, in an FDA statement. "Bupropion hydrochloride is a widely used antidepressant, and its generic version can bring significant savings to the millions of Americans with depression."
The FDA notes that Wellbutrin XL (bupropion hydrochloride) had sales of $1,326,323,000 in 2005, making it the 21st highest-selling brand-name drug in the United States. The FDA determined that its standards for approving the generic form were appropriate after receiving a citizen petition that asked that several issues be taken into account.