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Drug Development
Emezine NDA accepted for review by U.S. FDA
August 15th, 2005
BioDelivery Sciences International, Inc., (BDSI, BDSIW) announced that it has received written notification from the U.S. Food and Drug Administration that its new drug application (NDA) for Emezine has been accepted for review. BDSI previously announced that it filed such NDA in late April 2005, and this written notification indicates that FDA review of the product is now underway. Under FDA regulations, the FDA has up to 10 months from the date of NDA submission to review and render a decision on the application as to whether it is approvable or not. Emezine is a formulation of prochlorperazine, a currently approved agent for the treatment of...
Source: Pharma Business Week (2005-08-15)
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