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FDA Advisory Committee Recommendation on SEROQUEL XR Supplemental New Drug Applications
Date:4/20/2009

WILMINGTON, Del., April 8 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

The Advisory Committee concluded:

  • SEROQUEL XR was shown to be effective in MDD as both monotherapy and adjunctive therapy, and shown to be effective in GAD as monotherapy.
  • SEROQUEL XR was shown to be acceptably safe as an adjunctive treatment for MDD.
  • SEROQUEL XR was not shown to be acceptably safe as a monotherapy for broad treatment for MDD.
  • The committee was undecided as to whether SEROQUEL XR was shown to be acceptably safe in certain instances as a monotherapy treatment for MDD.
  • SEROQUEL XR was not shown to be acceptably safe as a monotherapy for the treatment of GAD.

Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: "We are pleased that the committee found SEROQUEL XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. Although the committee recognized the effectiveness of SEROQUEL XR as monotherapy for MDD and GAD, they had concerns around the long-term safety profile in these new populations. We look forward to having further discussions with the FDA regarding both sNDAs."

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 usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.


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SOURCE AstraZeneca
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