2017 Year-End Update on FDA Approved Thin Film Products

The US Food and Drug Administration (FDA) approved its last novel drug of 2017, Giaprezaon to increase blood pressure in adults with septic or other distributive shocks on December 21st of last year. Giaprezaon brought the total Novel Drug Approvals for the year to 46. According to a Pharma Compass article published in Jan of 2018 (https://www.pharmacompass.com/radio-compass-blog/2017-closes-with-record-approvals-of-generics-novel-drugs-2018-begins-with-reprieves-for-teva), 46 approvals is a new record for the FDA. In addition, the FDA also had a record number of generic drug approvals, the most ever novel devices, and the first ever gene therapies. Unfortunately, there were no new oral thin film or mucosal thin film products approved by the FDA in 2017. The last two products approved by the FDA under the 505(b)(2) path were Belbuca® for chronic pain and Bunavail® for opioid addiction. A company by the name of BioDelivery Sciences International (BDSI) is the NDA holder of these two products. With 3 of the 6 thin film products approved by the FDA, BDSI is certainly a market leader in this dosage form. From the chart below, one can see that thin film products center around a few large markets including pain, opioid addiction, and vomiting & nausea. ARx is pleased to share that we have partnered on 50% of the programs listed below to get the products approved by the FDA and available to patients in need. We also hope to add additional products to this list in 2018. Contact us to learn more about the benefits of thin film drug delivery.