Actavis Group receives FDA approval to market Bupropion HCl SR tablets

Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Bupropion HCl Extended-Release (SR) tablets 100mg and 200mg.  Distribution of the product will commence immediately.  

Bupropion HCl SR Tablets, the generic equivalent of Wellbutrin® SR by GlaxoSmithKline, are now available from Actavis in the following strengths: 100mg, 150mg, and 200mg.  Bupropion HCl SR is used in the treatment of major depressive disorder.  Annual U.S. sales of Wellbutrin® SR 100mg and 200mg and the generic equivalent in that strength was US$115 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.  

Commenting on the new approval, Michael Perfetto, Vice President of Sales & Marketing in the United States said:

"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."