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Favorable Vote From FDA Advisory Committee on SEROQUEL Pediatric Supplemental New Drug Applications

WILMINGTON, Del., June 10 /PRNewswire/ -- Today, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee conducted a review of the efficacy and safety of supplemental new drug applications (sNDAs) for SEROQUEL (quetiapine fumarate) tablets proposed for the acute treatment of schizophrenia in adolescents (13-17 years of age), and the acute treatment of bipolar mania in children and adolescents (10-17 years of age).

    The Advisory Committee voted as follows:

    Questions to the Advisory Committee              Yes    No   Abstain
    1. Has Seroquel been shown to be effective
       for the treatment of schizophrenia in
       pediatric patients ages 13-17?                 17     1      0
    2. Has Seroquel been shown to be acceptably
       safe for the treatment of schizophrenia in
       pediatric patients ages 13-17?                 16     0      2
    3. Has Seroquel been shown to be effective
       for the treatment of bipolar mania in
       pediatric patients ages 10-17?                 17     0      1
    4. Has Seroquel been shown to be acceptably
       safe for the treatment of bipolar mania
       in pediatric patients ages 10-17?              13     0      5

Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: "We are pleased that the committee found SEROQUEL to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with bipolar mania, and we look forward to having further discussions with the FDA regarding the sNDAs."

The current approved indications for SEROQUEL are unchanged. SEROQUEL is not approved for use in patients under the age of 18 in any country.

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency

SOURCE AstraZeneca
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