Supplier News Breaks Archives
Mylan sANDA approved for Wellbutrin generic
August 22nd, 2013
PITTSBURGH – Mylan Inc. has gained approval from the Food and Drug Administration for its supplemental Abbreviated New Drug Application (sANDA) providing bioequivalence study results for bupropion hydrochloride extended-release tablets (300 mg).
The company said Thursday that in December 2012, the FDA requested that all generic drug companies marketing a version of bupropion HCl ER Tablets 300 mg perform a fasting bioequivalence study comparing their product to GlaxoSmithKline's Wellbutrin XL tablets, (300 mg).
This past April, Mylan submitted to the FDA a sANDA containing the requested study, which the company said demonstrated bioequivalence of its bupropion HCl ER tablets 300 mg to Wellbutrin XL tablets 300 mg.
Mylan launched its bupropion HCl ER tablets, in dosages of 150 mg and 300 mg, to the U.S. market in September 2010.
Bupropion HCl ER tablets, the generic version of Wellbutrin XL, are indicated for the treatment of major depressive disorder.
For the 12 months ended June 30, bupropion HCl tablets 150 mg and 300 mg had U.S. sales of about $503.3 million, according to IMS Health data cited by Mylan.