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(From Chemical Business NewsBase - Press Release)
Solvay Pharmaceuticals Inc and Wyeth Pharmaceuticals announced that a New Drug Application (NDA) was submitted to the US Food and Drug Administration (FDA) for bifeprunox, an investigational atypical antipsychotic for the treatment of schizophrenia. The NDA submission is based on safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia in about 2550 patients. Patients were evaluated with acute exacerbations for six weeks, and stable patients were evaluated for six months. In Mar 2004, Solvay Pharmaceuticals and Wyeth entered into a …