Strativa’s NDA for ODFS Accepted by FDA

Strativa announced that the FDA has accepted its New Drug Application (NDA) for ondansetron orally dissolving film strip (ODFS) for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

The ODFS, a new oral formulation of ondansetron designed to rapidly dissolve on the tongue, was developed using MonoSol Rx’ proprietary PharmaFilm thin film technology.

In clinical studies, this formulation demonstrated bioequivalence to ondansetron orally disintegrating tablets (ODT), both with and without water. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Strativa expects the FDA will complete its review or otherwise respond to the NDA by the first quarter of 2010.

John A. MacPhee, President, Strativa Pharmaceuticals, said: We are very pleased with the acceptance of our NDA submission and look forward to cooperating with the FDA on its review.

We believe the quick dissolving film strip formulation of ondansetron offers a convenient and easy-to-administer option for managing nausea and vomiting associated with chemotherapy, radiotherapy and surgery, he added.