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news.The Food and Drug Administration has approved the first generic version of Wellbutrin XL, which is indicated for the treatment of major depressive disorder and is to be sold by GlaxoSmithKline and Biovail.
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“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 Buehler, director, Office of Generic Drugs.
The FDA believes the generic drug approval program are significant because generic drug products, which are used to fill over 50% of all prescriptions, frequently cost a fraction of the price of the brand-name drugs. According to the FDA, in 2005 Wellbutrin XL was the 21st highest-selling brand-name drug in the US.
After reviewing the generic version of Wellbutrin XL, bupropion hydrochloride, the FDA determined that its standards for approval of the generic drug application for bupropion are appropriate, including how similarly the drug is absorbed into the bloodstream.
Bupropion hydrochloride extended-release tablets, 150 mg and 300 mg are manufactured by Anchen Pharmaceuticals.