federal_register: 2018-25480

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2018-25480 Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), 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 issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that AJOVY (fremanezumab-vfrm), approved September 14, 2018, meets the redemption criteria. 2018-11-23 2018 11 https://www.federalregister.gov/documents/2018/11/23/2018-25480/approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucher https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-25480.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation...

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