Wyeth and Solvay Pharmaceuticals received a “not approvable” letter from the FDA in response to the NDA for bifeprunox, an atypical antipsychotic for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The FDA stated in the letter that bifeprunox demonstrated effectiveness in its long-term maintenance study and indicated that a second positive maintenance study could be sufficient to support a maintenance claim for bifeprunox. The compani...