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news.The FDA has accepted for filing BioDelivery Sciences International's new drug application for Bema Fentanyl for the management of breakthrough cancer pain in opioid tolerant patients.
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The acceptance of the new drug application (NDA), which was submitted on October 31, 2007, means the FDA has made an initial determination that the NDA is sufficiently complete to warrant a substantive review. A final decision by FDA is expected in August 2008.
If Bema Fentanyl is approved by the FDA, BioDelivery Sciences International (BDSI) is expected to receive milestone payments from its commercial partner, Meda, totaling $30 million and could begin receiving royalty revenues from the product as early as fourth quarter of 2008.