BioDelivery Sciences (BDSI) Reaches Agreement with FDA on NDA for ONSOLIS(TM)
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BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced that the company has reached agreement with the U.S. FDA Division of Anesthesia, Analgesia and Rheumatology Products and a multidisciplinary review team on all aspects of the company's New Drug Application for ONSOLIS(TM) (fentanyl buccal soluble film), including the Risk Evaluation and Mitigation Strategy. Although the FDA did not meet its action date of last Friday for this NDA, the Division has informed the company that FDA will not be issuing a review extension letter as their action on the NDA is forthcoming.
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