BioDelivery Sciences International, Inc., announced that the FDA has approved the company’s sNDA for a manufacturing specification change for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII). The approval allows for the immediate release of BUNAVAIL inventory to wholesalers. BDSI will be shipping product to wholesalers this morning which should make product available in pharmacies as early as Friday.
The newly released product supplies are expected to satisfy current and anticipated demand, which has increased following the October 1 initiation of a contract providing exclusive, preferred formulary status for BUNAVAIL for Medicaid patients in the state of Tennessee.
Meanwhile, in Canada, Baxalta Incorporated’s OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] was approved by Heath Canada for the treatment of bleeding episodes in patients with acquired hemophilia A caused by autoantibodies to coagulation Factor VIII (FVIII), a very rare and life-threatening acute bleeding disorder. OBIZUR is the first recombinant porcine sequence FVIII treatment available for patients with acquired hemophilia A, specifically designed to enable physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments.
