FDA Panel Will Review Seroquel XR

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Wednesday, 04 March 2009 08:06

WASHINGTON, March 3 (Reuters) - U.S. regulators will ask outside advisers for input on safety concerns surrounding expanded use of AstraZeneca Plc's (AZN.L) schizophrenia drug Seroquel XR, the Food and side effects of cialis Drug Administration said on Tuesday.

The issues for discussion at the compare prices viagra April 8 advisory panel meeting include "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and 5 mg cialis a possible risk of tardive dyskinesia," an FDA notice said.

Tardive dyskinesia causes involuntary, repetitive movement of the cheap viagra tablets limbs and buy viagra china lip smacking, grimacing and brand cialis for sale other symptoms that can be permanent.

Seroquel is AstraZeneca's second-best-selling drug, with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formulation.

AstraZeneca is seeking FDA approval to market Seroquel XR for treating depression and buy pfizer viagra online anxiety. The drug is already sold for treatment of schizophrenia and the cheap viagra bipolar disorder. Those already-approved uses are not a part of the advisory committee review, AstraZeneca spokeswoman Abigail Baron said.

"AstraZeneca fully supports the work of the FDA in conducting a full review of the potential benefits and free generic cialis risks of Seroquel XR in the treatment of major depressive disorder and viagra cost generalized anxiety disorder," she said.

Seroquel's prescribing instructions include warnings about weight gain and generic viagra a diabetes as well as increases in cholesterol levels. Tardive dyskinesia also is mentioned as a possible complication.

The FDA will consider the advisory panel's recommendations before deciding whether to approve the new uses. The agency usually follows the advice of the outside panels. (Reporting by Lisa Richwine, editing by Gunna Dickson and viagra sale Gerald E. McCormick)





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