December 18, 2006

Generic Wellbutrin XL Approved

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


I have been on the generic Buderprion xl 300 for a month now and since then, am suffering from a severe dermatitis as well as horrific headaches. Headaches similar to those I have experienced when being without my wellbutrin for 3 or more days, due to losing or not having the prescription with me. Is this a common side-effect? Is it possible that the generic does not agree with me or could contain ingredients I am allergic to? Please advise.

Posted by: bee at July 21, 2007 10:13 AM

I will say that I have exact same problem (headaches at least). My insurance company is horrible and doesn't want me taking the brand name. I simply cannot afford the 300 XL Wellbutrin, and yet when I take the generic 300's I get unbelievable headaches. I did recently try it again (the generic 300), because the difference in cost (to me) is about $90/month if I use the generic. However, I simply cannot tolerate the generic due to the headache. My doctor has now prescribed me the 150 XL brand name, and though it may not be ideal, it is certainly better than the headache. It only costs me $25/month. I started yesterday with the brand name, and whallah! No headache today. Anyone who says there is no difference in brand name and generic is WRONG!

Posted by: Holly at January 18, 2008 12:47 PM

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