Issuance of Priority Review Voucher; Rare Pediatric Disease Product; EMCITATE (Tiratricol)

Issuing agencies

Abstract

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 EMCITATE (tiratricol), approved September 28, 2026, manufactured by Rare Thyroid Therapeutics International AB meets the criteria for a priority review voucher.

Full Text

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<title>Federal Register, Volume 91 Issue 207 (Wednesday, October 28, 2026)</title>
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[Federal Register Volume 91, Number 207 (Wednesday, October 28, 2026)]
[Notices]
[Page 67840]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-12279]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product; EMCITATE (Tiratricol)

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 EMCITATE (tiratricol), approved September 28, 2026, manufactured 
by Rare Thyroid Therapeutics International AB meets the criteria for a 
priority review voucher.

FOR FURTHER INFORMATION CONTACT: Scott Winiecki, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Silver Spring, MD 20993-0002, 301-771-1519 
<a href="/cdn-cgi/l/email-protection#6d3e0e021919433a040304080e06042d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="194a7a766d6d374e7077707c7a7270597f7d783771716a377e766f">[email&#160;protected]</span></a>.

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 EMCITATE (tiratricol), manufactured by Rare Thyroid 
Therapeutics International AB meets the criteria for a priority review 
voucher. EMCITATE (tiratricol) tablet is indicated for the treatment of 
peripheral thyrotoxicosis in adults and pediatric patients with 
monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley 
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 <a href="https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm">https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm</a>. For further 
information about EMCITATE (tiratricol) go to the ``Drugs@FDA'' website 
at <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">https://www.accessdata.fda.gov/scripts/cder/daf/</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21911 Filed 10-27-26; 8:45 am]
BILLING CODE 4164-01-P


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