FDA Approves Mylan Sumatriptan Succinate Tablets (ANDA 077744)

The U.S. Food and Drug Administration (FDA) has granted approval for an Abbreviated New Drug Application (ANDA) numbered 077744 submitted by Mylan Pharmaceuticals Inc. The approved product is sumatriptan succinate, an oral tablet indicated for prescription use, available in three strengths: 25 mg, 50 mg, and 100 mg (equivalent to base). The application’s submission history includes several labeling supplements: submission numbers 2 (approved 11 Jan 2012), 4 (approved 19 Jun 2015), 5 (approved 19 Jun 2015), 8 (approved 16 Apr 2019), and 13 (approved 31 Mar 2023). A manufacturing (CMC) submission (number 11) was approved on 1 Jul 2021. The original application letter is dated 14 Aug 2009. All three tablet strengths are classified as human prescription drugs and are marketed under the brand name “SUMATRIPTAN SUCCINATE.” The FDA’s approval reflects compliance with labeling and manufacturing requirements for the product.