FDA approves additional strengths of Actavis' generic Wellbutrin SR
MORRISTOWN, N.J. Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant, the drug maker announced Wednesday.
Actavis said it immediately will begin distributing its bupropion HCl extended-release (SR) tablets in 100-mg and 200-mg strengths. The drug is the generic equivalent of GlaxoSmithKline's Wellbutrin SR. Actavis already has marketed generic Wellbutrin SR in the 150-mg strength. The drug maker received approval in March 2008.
Annual U.S. sales of Wellbutrin SR 100-mg and 200-mg and the generic equivalent in that strength was $115 million for the 12 months ended in March, according to IMS Health data.