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Forest Laboratories, Inc.
Company submits response to U.S. FDA regarding Lexapro for panic disorder
September 24th, 2004
Forest Laboratories, Inc., (FRX) announced that it has submitted a complete response to deficiencies raised by the FDA (U.S. Food and Drug Administration) Division of Neuropharmacological Drug Products in its review of the panic disorder supplemental new drug application (NDA) submitted for Lexapro in April, 2003. Lexapro is approved for use in major depressive disorder and generalized anxiety disorder. An additional supplemental NDA is under FDA review for social anxiety disorder. The FDA notified Forest Laboratories on February 25, 2004, that the supplemental NDA for panic disorder was not approvable based on deficiencies with...
Source: Food & Drug Law Weekly (2004-09-24)
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