Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL), 300mg.
Bioequivalence study results of Bupropion Hydrochloride (HCl) Extended-release (ER) Tablets USP (XL), 300mg were included in the sANDA.
The generic product, indicated to treat major depressive disorder (MDD), has been launched in 150mg and 300mg strengths, to the US market in September 2010.
Bupropion Hydrochloride Extended-release Tablets, 150mg and 300mg, had US sales of approximately $503.3m for the 12 months ending on 30 June 2013, according to IMS Health.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/mylan-wins-fda-approval-for-bupropion-hydrochloride-extended-release-tablets-sanda-230813
