Reuters - Johnson & Johnson said on Friday U.S. regulators rejected its application to market antipsychotic drug Risperdal for patients with autism. Johnson & Johnson’s Pharmaceutical Research & Development unit said it received a “not-approvable” letter from the U.S. Food and Drug Administration on its petition for an additional use of the drug, which currently is used as a treatment for schizophrenia.
J&J said given the lack of treatments for autism, it will evaluate the letter and determine the appropriate next steps. In April, the FDA ordered new warnings on all antipsychotic drugs, including Risperdal, to alert physicians to a higher death rate when the medicines are prescribed for the atypical use of treating dementia in elderly patients.
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