US FDA approves BioDelivery Sciences’ sNDA for manufacturing specification change for Bunavail

The US Food and Drug Administration (FDA) has approved BioDelivery Sciences International Inc’s Supplemental New Drug Application (sNDA) for a manufacturing specification change for Bunavail (buprenorphine and naloxone) buccal film (CIII).

Bunavail is a prescription medicine indicated for the maintenance treatment of opioid dependence.

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.

What is sNDA? 

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