Approval of J&J's Antipsychotic Delayed for Teens

U.S. regulators delayed a request by Johnson & Johnson to expand use of its top-selling Risperdal to include schizophrenia and bipolar disorder in adolescents.

The FDA didn't request new studies on the treatment in a letter to the company, J&J said in a statement today. J&J said it would work with the agency to complete prescribing information on the drug, which is already approved for use in children with autism and adults with schizophrenia and bipolar disorder.

Use of antipsychotic drugs for younger patients has risen sharply in recent years, prompting concern among some doctors and parents about side effects including weight gain and diabetes. Risperdal, which generated $4.2 billion last year, is the second such drug delayed by U.S. regulators for teen use. Eli Lilly's Zyprexa was held up in April.

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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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Johnson n Johnson schizophrenia drug gets wider US approval

Johnson & Johnson said on Friday that U.S. health regulators have broadened the approval for its Invega antipsychotic drug as a long-term maintenance treatment for schizophrenia.

The drug, a longer-acting version of J&J’s Risperdal, was approved in December to treat acute, or short-term, schizophrenia.

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