FDA Delays Approval For Teva LAI Antipsychotic

The U.S. Food and Drug Administration (FDA) notified Teva Pharmaceuticals and MedinCell that it needed more information before it could approve Teva’s New Drug Application (NDA) for a long-acting injected formulation of the antipsychotic risperidone. The medication is intended for treatment of schizophrenia. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations. Teva and Medincell remain committed to the development of risperidone and to providing patients with access to the product in the U.S., as quickly as possible.

The NDA included Phase 3 data from . . .