Teva Pharmaceutical Says FDA Accepts New Drug Application for Olanzapine in Schizophrenia Treatment

MT Newswires Live02-21 04:05

Teva Pharmaceutical Industries (TEVA) said Friday that the US Food and Drug Administration has accepted the company's New Drug Application for olanzapine extended-release injectable suspension, or TEV-'749, for the treatment of schizophrenia in adults.

The application for TEV-'749 is based on results from the phase 3 Solaris trial that demonstrated an efficacy and safety profile consistent with other available olanzapine formulations, and showed no evidence for the need for post-injection monitoring, Teva Pharmaceutical Industries said.

Shares of the company were down over 1% in recent Friday trading.

Price: 34.00, Change: -0.33, Percent Change: -0.96

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