U.S. regulators will ask outside advisers for input on safety concerns surrounding expanded use of AstraZeneca's schizophrenia drug Seroquel XR, the Food and Drug Administration said on Tuesday.
AstraZeneca is seeking FDA approval to market Seroquel XR for treating depression and anxiety. The drug is already sold for treatment of schizophrenia and bipolar disorder.
The issues for discussion at the April 8 advisory panel meeting include "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia," an FDA notice said.
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The issues for discussion at the April 8 advisory panel meeting include "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia," an FDA notice said.
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