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2003
30 October 2003
2003-10-30T13:15:00.0000000-00:00
ASTRAZENECA RECEIVES FDA APPROVABLE LETTER FOR SEROQUEL™ (QUETIAPINE FUMARATE) TABLETS IN TREATMENT OF MANIA
AstraZeneca today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its Supplemental New Drug Applications (sNDAs) for the use of SEROQUEL as both an adjunct and monotherapy for the treatment of manic episodes associated with bipolar disorder. The company is working closely with the FDA to supply information and to finalize labelling.
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