FDA approves new formulation of Onsolis (fentanyl buccal soluble film) for pain treatment-BioDelivery Sciences
BioDelivery Sciences announced the approval by the FDA of a Supplemental New Drug Application for a new formulation of Onsolis (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. The new formulation was submitted to address previously announced appearance-related changes.
Comment: Early this year, BDSI announced that it entered into an assignment and revenue sharing agreement with its partner for Onsolis, Meda Pharmaceuticals, to return the marketing authorization back to BDSI and the right to seek marketing authorizations for Onsolis in the United States, Canada and Mexico. Meda retains the rights to Onsolis outside the U.S., where it is marketed in the E.U. as BREAKYL. Onsolis is separately licensed by BDSI in Taiwan and South Korea.
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