Barr Pharmaceuticals, Inc. and its subsidiary Pliva d.d. announced that Pliva has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market sertraline hydrochloride tablets, 25 mg, 50 mg and 100 mg, generic versions of Pfizer Inc.'s Zoloft tablets.
The FDA issued final approval following the expiration of Teva Pharmaceuticals' 180-days of marketing exclusivity, as provided for under the Hatch-Waxman Act. The company intends to launch its product immediately, a Barr press release said.
Zoloft tablets (sertraline hydrochloride) had total annual sales of approximately $2.9 billion, based on IMS data for the twelve months ending December 2006. The company's sertraline hydrochloride tablets, 25 mg, 50 mg and 100 mg are indicated for the treatment in adults of major depressive disorder.