FDA Accepts Teva's New Long-Acting Schizophrenia Treatment Application

Teva Pharmaceuticals Industries Ltd (NYSE:TEVA) on Friday announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension.

Potential FDA Approval For Schizophrenia Drug

The marketing application for TEV-‘749 is based on results from the Phase 3 SOLARIS trial, which demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.

This investigational drug aims to improve treatment adherence for individuals living with schizophrenia, addressing a critical gap in care.

In the SOLARIS trial, TEV-‘749 was administered as a once-monthly subcutaneous injection, showing no evidence for the need for post-injection monitoring, which is typically required for other formulations.

The acceptance of this NDA marks a significant milestone ...

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FDA Accepts Teva's New Long-Acting Schizophrenia Treatment Application

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