FDA "approvable" letter for J&J's Risperdal sNDAs
Johnson & Johnson Pharmaceutical Research & Development has received an "approvable" letter from the US Food and Drug Administration regarding two supplemental New Drug Applications for Risperdal (risperidone), filed on December 21, 2006.
The sNDAs are for the treatment of schizophrenia in adolescents aged 13-17 years and as a short-term therapy of bipolar mania associated with bipolar I disorder in children and adolescents aged 10-17 years, respectively. The FDA has not asked for any additional studies. J&JPRD is currently reviewing the approvable letter and looks forward to finalizing the label with the agency.
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