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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