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FDA declines to authorize antipsychotic drug licensed to Forest

  • The FDA has decided not to authorize Cariprazine, a treatment for schizophrenia and bipolar disorder that Forest Labs (FRX) has licensed from Hungarian firm Gedeon Richter (GEDRY).
  • In a complete response letter, the FDA said Cariprazine demonstrated effectiveness, although it seems that the regulator wants more tests carried out on the optimal dose of the drug in order to avoid potential side effects.
  • Richter said it would be able to ascertain for certain whether more tests are needed following consultations with the FDA.
  • Analysts had forecast sales of $250M by 2017 if the treatment were to be approved. (PR)
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