Actavis has received approval from US Food and Drug Administration (US FDA) to market Bupropion HCl Extended-Release (SR) tablets 100mg and 200mg. Distribution of the product will commence immediately.
Bupropion HCl SR is used in the treatment of major depressive disorder.
Bupropion HCl SR tablets, the generic equivalent of GlaxoSmithKline's Wellbutrin SR, are now available from Actavis in the following strengths: 100mg, 150mg, and 200mg.
Annual sales of Wellbutrin SR 100mg and 200mg and the generic equivalent in that strength in the United States was USD115 million for the 12 months ending March 2010 according to IMS Health data.
The addition of the 100mg and 200mg Bupropion HCl SR complements Actavis’ already approved and marketed Bupropion HCl SR 150mg. Actavis received approval of Bupropion HCl SR 150mg in March, 2008.
Michael Perfetto, vice president of Actavis' Sales & Marketing in the US, “The approval of Bupropion SR 100mg and 200mg allows Actavis to provide the full range of strengths available on both Bupropion SR and XL products and offers a significant value to our customers and patients. This approval also underscores Actavis’ emphasis and commitment to bringing complex controlled-release products to the marketplace.”