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December 18, 2006
Generic Wellbutrin XL Approved
Read more... New Formulations of Existing Drugs
The U.S. Food and Drug Administration (FDA) has approved the first generic version of Wellbutrin XL (Bupropion hydrochloride) Extended-Release Tablets, which is indicated for the treatment of major depressive disorder (MDD).
In 2005, Wellbutrin XL, produced by GlaxoSmithKline, was the 21st highest-selling brand-name drug in the United States with sales exceeding $1.3 billion.
Anchen Pharmaceuticals Inc, of Irvine, California holds the license to manufacture the generic Bupropion Hydrochloride Extended-Release Tablets. They are producing the medication in 150 mg and 300 mg tablets.
Generic drugs now account for over 50 percent of all prescriptions sold in the United States.
About issues raised in a citizen petition (a formal request for FDA action) asking the FDA to consider several issues including how similarly the generic form of Wellbutrin XL is absorbed into the bloodstream, the FDA determined that its standards for approval of the generic drug application for bupropion are appropriate.
In spite of some individuals finding that they cannot interchange name-brand products and generics due to absorption and metabolic differences that their pharmacists say are due to different "inert ingredients" being used in their manufacture, the FDA has issued the following reassurance:
"Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, and route of administration, quality, performance characteristics, and intended use."
Read the FDA's news release: FDA Approves First Generic Bupropion Hydrochloride Extended-Release Tablets
Posted by Jeanie Wolfson at December 18, 2006 01:40 PM
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