Author Topic: A generic of Wellbutrin XL 300 has been withdrawn by FDA  (Read 2577 times)

olmphoto2

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A generic of Wellbutrin XL 300 has been withdrawn by FDA
« on: December 06, 2012, 05:37:19 AM »
This manufacturer cited is one of several making a generic of Wellbutrin XL 300---but please make note of what I have placed in italics in the quote below:

Withdrawal of Generic Budeprion for NonbioequivalenceJanet Woodcock, M.D., Mansoor Khan, R.Ph., Ph.D., and Lawrence X. Yu, Ph.D.
December 5, 2012DOI:  10.1056/NEJMp1212969

Here is an excerpt of the professional article
 published on December 5, 2012, at NEJM.org. (New England Journal of Medicine)


"...The Food and Drug Administration (FDA) has completed a head-to-head bioequivalence study of single doses of the generic drug Budeprion XL 300 mg (extended-release bupropion hydrochloride, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals) and the brand-name drug Wellbutrin XL 300 mg (Biovail). The agency has concluded that Budeprion XL 300 mg cannot be considered therapeutically equivalent to the brand-name product. We at the FDA are therefore changing our bioequivalence recommendations for extended-release bupropion products and have asked other manufacturers of 300-mg extended-release bupropion products to conduct additional bioequivalence studies."  [italics mine]

http://www.nejm.org/doi/full/10.1056/NEJMp1212969?query=TOC


For anyone using the 300 mg dose, you might call your pharmacist who would be able to tell you what generic was dispensed to you.

Mary Ann in Wisconsin

"A man will be imprisoned in a room with a door that is unlocked and opens inwards as long as it does not occur to him to pull rather than push." 
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