[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Page 61600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2607]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 SOHONOS (palovarotene), manufactured by Ipsen Biopharmaceuticals, 
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, 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), FDA will award priority review vouchers to sponsors of approved 
rare pediatric disease product applications that meet certain criteria. 
FDA has determined that SOHONOS (palovarotene), approved on August 16, 
2023, and manufactured by Ipsen Biopharmaceuticals, Inc., meets the 
criteria for a priority review voucher. SOHONOS (palovarotene) capsules 
are indicated for reduction in volume of new heterotopic ossification 
in adults and pediatric patients (aged 8 years and older for females 
and 10 years and older for males) with fibrodysplasia ossificans 
progressiva.
    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 http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about SOHONOS (palovarotene), go to the ``Drugs@FDA'' 
website at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19289 Filed 9-6-23; 8:45 am]
BILLING CODE 4164-01-P