BioDelivery Sciences International Submits REMS for ONSOLIS to FDA for Approval

RALEIGH, N.C.--(BUSINESS WIRE)--BioDelivery Sciences International, Inc., (NASDAQ:BDSI) announced that it has resubmitted its New Drug Application (NDA) for the company’s lead product ONSOLIS™ to the Food and Drug Administration (FDA). The company continues to anticipate that the resubmission, which includes a Risk Evaluation and Mitigation Strategy (REMS) for ONSOLIS, will be approved in the first half of 2009.
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