J&JPRD yet to review approvable letter and finalize label with FDA.
Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) received an approvable letter regarding two sNDAs for Risperdal®. The sNDAs are for the treatment of schizophrenia in adolescents between 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents between 10-17 years.
The FDA has not asked for any additional studies, according to J&JPRD. The company says that it is currently reviewing the letter and then will finalize the label with FDA.
Risperdal is already approved for the treatment of bipolar I disorder and acute to manic or mixed episodes associated with bipolar mania.