[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59622-59623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27049]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0809]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
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
[[Page 59623]]
the sponsor of a rare pediatric disease product application. The
Federal Food, Drug, and Cosmetic Act (the 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 award of the
priority review voucher. FDA has determined that MEPSEVII (vestronidase
alfa-vjbk), manufactured by Ultragenyx Pharmaceutical, Inc., meets the
criteria for a priority review voucher.
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-
796-9856, email: [email protected].
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), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
MEPSEVII (vestronidase alfa-vjbk), manufactured by Ultragenyx
Pharmaceutical, Inc., meets the criteria for a priority review voucher.
MEPSEVII (vestronidase alfa-vjbk) is indicated for the treatment of
Mucopolysaccharidosis type VII (MPS VII, Sly Syndrome).
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 MEPSEVII (vestronidase alfa-vjbk), go to the
``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27049 Filed 12-14-17; 8:45 am]
BILLING CODE 4164-01-P