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FDA Issues Approvable Letter for RISPERDAL? to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
Titusville, NJ (June 21, 2007) -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding two supplemental New Drug Applications (sNDA) for RISPERDAL? (risperidone), filed on Dec. 21, 2006. The sNDAs are for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 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.
Titusville, NJ (June 21, 2007) -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding two supplemental New Drug Applications (sNDA) for RISPERDAL? (risperidone), filed on Dec. 21, 2006. The sNDAs are for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 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.
