FDA extends PDUFA date for Probuphine (buprenorphine implant)for maintenance treatment of opioid addiction to 27 May 2016.- Titian Pharma + Braeburn Pharma
Titan Pharmaceuticals, Inc. announced that the FDA has notified Titan and its development and commercialization partner Braeburn Pharmaceuticals that it will require additional time to review the New Drug Application for Probuphine for the maintenance treatment of opioid addiction. The FDA has extended the date for agency action by the standard period, from Feb. 27, 2016 to May 27, 2016.
Following the Psychopharmacologic Advisory Committee meeting in January, the FDA requested additional changes to the Risk Evaluation and Mitigation Strategy (REMS) portion of the NDA, which were promptly submitted by Braeburn. The FDA determined that the submission qualified as a major amendment to the NDA during the review process and elected to extend the action date.
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