BioDelivery Sciences International, Inc. Reaches Agreement on REMS With FDA Review Division
6:00am EDT
BioDelivery Sciences International, Inc. announced that it has reached agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology Products and a multidisciplinary review team on all aspects of the Company's New Drug Application (NDA) for ONSOLIS (fentanyl buccal soluble film), including the Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its action date of last 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. BDSI received a Complete Response letter from FDA on the NDA for ONSOLIS on August 28, 2008, with the only deficiency being the new requirement for a REMS. The REMS was not required at the time the NDA was originally submitted to FDA in October 2007. The REMS was formally submitted to the FDA on December 12, 2008 and the submission was placed under a six month review period.
