Teva submits NDA to U.S. FDA for olanzapine

Teva (TEVA) Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced the submission of a New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for olanzapine extended-release injectable suspension for the treatment of schizophrenia in adults. The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia. The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia.