Teva Pharmaceuticals (TEVA) said Tuesday it has submitted a new drug application to the US Food and Drug Administration of its once-monthly olanzapine extended-release injection, TEV-749, to treat schizophrenia in adults.
The application is based on a phase 3 study in adults aged 18 to 64 that found that the long-acting under-the-skin treatment met efficacy and safety goals with results in line with oral version of the same drug, the company said.
The experimental injection uses Medincell's SteadyTeq technology to deliver a steady monthly dose of olanzapine, Teva said.
Shares of the company were up 1.7% in recent Tuesday trading.
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