Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Gomekli (mirdametinib)

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2020-N-0026] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that GOMEKLI (mirdametinib), approved on February 11, 2025, manufactured by SpringWorks Therapeutics, Inc., meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394. SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act ( 21 U.S.C. 360ff ), FDA will ( printed page 11993) award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that GOMEKLI (mirdametinib), manufactured by SpringWorks Therapeutics, Inc., meets the criteria for a priority review voucher. GOMEKLI…