FDA APPROVES FIRST GENERIC ONDANSETRON TABLETS

Generic firms Barr Pharmaceuticals and Dr. Reddy's Laboratories won FDA approval to market ondansetron, a generic version of GlaxoSmithKline's Zofran ODT indicated for the prevention of nausea and vomiting associated with cancer chemotherapy.

The Dec. 26 approval awards both generic firms the 180-day marketing exclusivity period.

Barr, through a special agreement between its subsidiary Pliva and Par Pharmaceuticals, will market generic ondansetron orally disintegrating tablets in 4- and 8-mg doses. Specific terms of the agreement give Pliva exclusive rights to market the drug. The companies will split the profits from product sales, Barr said.

Dr. Reddy's has been approved to market ondansetron hydrochloride tablets in 4-, 8-, 16- and 24-mg doses.

Barr and Dr. Reddy's said they plan to ship generic ondansetron immediately.

Teva Pharmaceutical had won FDA approval to market generic versions of ondansetron injections in single 4-mg/2-mL doses and in multiple doses in 40-mg/20-mL vials.

Annual U.S. sales of Zofran are approximately $300 million, according to IMS Health.