FDA GRANTS MYLAN'S GENERIC ZOFRAN ANDA TENTATIVE APPROVAL

Mylan Laboratories announced that Mylan Pharmaceuticals has received tentative approval from the FDA for its abbreviated new drug application (ANDA) for ondansetron orally disintegrating tablets, 4 and 8 mg.

The product is the generic version of GlaxoSmithKline's Zofran ODT, which had U.S. sales of approximately $314 million for the same strengths during 2006, according to IMS Health.

Barr Pharmaceuticals and Dr. Reddy's Laboratories first won FDA approval to market generic ondansetron in January, and both companies were granted 180 days of marketing exclusivity.

Zofran ODT is indicated for the prevention of nausea and vomiting associated with cancer chemotherapy.