Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Jun 21, 2007

Schizophrenia and Bipolar Mania Treatment in Adolescents and Children Added to Risperdal’s Label

  • 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.



Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »