FDA Delays Risperdal For Teenagers

Untold numbers 0f kids may be prescribed antipsychotics on an off-the-label basis every year, but the FDA held back from giving Johnson & Johnson its blessing to market the drug officially to teenagers suffering from schizophrenia.

The agency has issued an approvable letter in response to the drugmaker’s request to market Risperdal for schizophrenia in youngsters between 13 and 17, and for short-treatment of bipolar mania associated with bipolar I disorder in kids between 10 and 17. J&J was quick to note, however, that the FDA didn’t request new studies, according to its statement today.

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