FDA approves Mylan antidepressant after company reaffirms efficacy

Agency asked makers of generic bupropion hydrochloride extended-release tablets to conduct studies on equivalence to branded version

PITTSBURGH — The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

The drug maker announced the approval of its supplemental abbreviated new drug application, or sANDA, for bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL.

Last year, the FDA requested makers of generic versions of Wellbutrin XL to conduct studies to determine whether their versions were equivalent to the branded drug following reports that a company's generic version had lower efficacy. By law, all generic drugs must be as safe and effective as their branded counterparts.

Bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths had sales of about $503.3 million during the 12-month period that ended in June, according to IMS Health.

 

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