STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News: The U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to BioDelivery Sciences International (BDSI) for Onsolis - formerly known as BEMA Fentanyl, in the U.S. The implication is that the FDA in principal accepts the registration application but requests certain modifications to the submitted risk management program. FDA has stated that all other aspects of the registration application were complete and no other deficiencies were noted. The FDA will be provided with a resubmission allowing for an anticipated approval during first half of 2009.
