Opportunity
Federal Register #2026-21911
FDA Announces Priority Review Voucher for EMCITATE (Tiratricol)
Buyer
Food and Drug Administration
Posted
October 28, 2026
Identifier
2026-21911
The FDA notice announces a rare pediatric disease priority review voucher associated with EMCITATE (tiratricol), rather than a request to buy products or services. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Notice: The FDA reports issuing a rare pediatric disease priority review voucher to the sponsor of the approved EMCITATE product application. - OEM/manufacturer: Rare Thyroid Therapeutics International AB, identified as the manufacturer of EMCITATE. - Product and use: EMCITATE (tiratricol) tablets are indicated to treat peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency, also known as Allan-Herndon-Dudley syndrome. - Procurement status: This is an award announcement, not a solicitation; no quantities, part numbers, or services are requested.
Description
The FDA announces the issuance of a priority review voucher to the sponsor of the rare pediatric disease product EMCITATE (tiratricol). FDA determined that the product, approved September 28, 2026, and manufactured by Rare Thyroid Therapeutics International AB, meets the criteria for a voucher. EMCITATE is indicated to treat peripheral thyrotoxicosis in adults and pediatric patients with MCT8 deficiency (Allan-Herndon-Dudley syndrome).