Mylan and Par pass FDA scrutiny on Wellbutrin generics

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Mylan and Par pass FDA scrutiny on Wellbutrin generics

Generics/News | Posted 06/09/2013 0 Post your comment

Mylan and Par Pharmaceutical (Par) announced on 20 and 22 August 2013, respectively, that they have passed FDA scrutiny of their generics of antidepressant Wellbutrin XL (bupropion).

The extra scrutiny comes after FDA received complaints from patients that the 300 mg generic version of the drug made by Teva Pharmaceutical Industries (Teva) did not work [1]. FDA subsequently carried out a study which showed that Teva’s generic drug did not release the active ingredient at the same rate and extent as the brand-name drug. This prompted FDA, in September 2012, to require the other makers of 300 mg generics of Wellbutrin to conduct their own bioequivalence studies and provide data to FDA by March 2013 at the latest.

The announcements from Mylan and Par confirm that their supplemental abbreviated new drug applications (ANDAs), which demonstrated in vivo bioequivalence of their 300 mg extended-release generic bupropion, to Wellbutrin, 300 mg.

The original ANDAs were accepted using data extrapolated from the 150 mg strength.

This is good news for the generics manufacturers, which can now continue to market their generics. For the 12 months ending 30 June 2013, bupropion extended-release tablets, 150 mg and 300 mg had US sales of approximately US$503.3 million, according to IMS Health.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Teva withdraws generic antidepressant from US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 6]. Available from: www.gabionline.net/Generics/News/Teva-withdraws-generic-antidepressant-from-US

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Source: Mylan, Par Pharmaceutical