Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher

• Published date: 06 September 2019
• Citation: 84 FR 46956
• Record Number: 2019-19298
• Section: Notices
• Court: Food And Drug Administration

Federal Register, Volume 84 Issue 173 (Friday, September 6, 2019)

[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
                [Notices]
                [Page 46956]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-19298]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2018-N-1262]
                Notice of Approval of Product Under Voucher: Rare Pediatric
                Disease Priority Review Voucher
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice.
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                SUMMARY: 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 RINVOQ (upadacitnib) approved August 16, 2019, meets
                the redemption criteria.
                FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
                Evaluation and Research, Food and Drug Administration, 10903 New
                Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
                796-9858, email: [email protected].
                SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C.
                360ff), which was added by FDASIA, FDA will report the issuance of rare
                pediatric disease priority review vouchers and the approval of products
                for which a voucher was redeemed. FDA has determined that RINVOQ
                (upadacitnib) approved August 16, 2019, meets the redemption criteria.
                 For further information about the Rare Pediatric Disease Priority
                Review Voucher Program and for a link to the full text of section 529
                of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
                information about RINVOQ (upadacitnib) approved August 16, 2019, go to
                the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
                 Dated: September 3, 2019.
                Lowell J. Schiller,
                Principal Associate Commissioner for Policy.
                [FR Doc. 2019-19298 Filed 9-5-19; 8:45 am]
                BILLING CODE 4164-01-P