FDA Approves ANDA210272 for Buprenorphine Transdermal Patch

The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) 210272 for a buprenorphine transdermal patch. The approved product is marketed under the brand name BUPRENORPHINE, is a prescription‑only, transdermal film with extended‑release delivery. Five dosage strengths are listed: 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, and 20 mcg/hr, each identified by product numbers 001‑005. The manufacturers named in the submission are INGENUS PHARMACEUTICALS, LLC and Aveva Drug Delivery Systems Inc. The product is classified as a human prescription drug and is subject to a Risk Evaluation and Mitigation Strategy (REMS). The original submission (submission number 1) received approval on 23 September 2021. A supplemental submission (submission number 8) with a REMS classification was approved on 31 October 2024.