FDA approves Par's generic bupropion hydrochloride extended-release tablets

Generic version of Wellbutrin XL approved following new FDA policy

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical Cos., the drug maker said Tuesday.

Par announced the approval of bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL and is used to treat major depressive disorder. The company already markets the generic drug in the 150-mg strength.

In September 2012, the FDA asked companies making generic bupropion hydrochloride extended-release tablets to conduct studies in order to ensure that their versions were as effective as the branded version following reports of differences in efficacy between the branded drug and some generics. Par said it conducted a study demonstrating that its version was equivalent to GSK's.


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