Pliva, Mylan and Actavis get US OK for generic Zoloft

Three drugmakers have received final US Food and Drug Administration approval to market sertraline HCl the generic version of Pfizer's blockbuster Zoloft, in 25mg, 50mg and 100mg doses. These were Barr's subsidiary Pliva, Mylan Laboratories and Icelandic firm Actavis.

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 three companies all said they intend to launch their products immediately.

Zoloft, indicated for the treatment in adults of major depressive disorder, achieved sales of around 2.9 billion last year, according to IMS Health data.