FDA declines to move forward with schizophrenia treatment
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The FDA has issued a Complete Response Letter for the New Drug Application for risperidone extended-release injectable for subcutaneous use, a schizophrenia treatment, Teva Pharmaceuticals and MedinCell announced in a statement.
The FDA states on its website that it will send a Complete Response Letter if the agency determines it will not approve the application in its present form.
According to Teva and MedinCell, the NDA submitted included data from two phase 3 trials, which evaluated the safety, efficacy and tolerability of the treatment.
Both companies stated that they are committed to the development of risperidone and to providing Americans access as quickly as possible. Teva said it is working closely with the FDA on its next steps to address the recommendations.