Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate)

---
identifier: "/us/fr/2026-03925"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate)"
title_number: 0
title_name: "Federal Register"
section_number: "2026-03925"
section_name: "Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate)"
positive_law: false
currency: "2026-02-27"
last_updated: "2026-02-27"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2026-03925"
document_type: "notice"
publication_date: "2026-02-27"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "91 FR 9864"
fr_volume: 91
docket_ids:
  - "Docket No. FDA-2026-N-1486"
fr_action: "Notice."
---


#  Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate)

**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 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 ZYCUBO (copper histidinate), approved January 12, 2026, manufactured by Sentynl Therapeutics Inc., meets the criteria for a priority review voucher.

**FOR FURTHER INFORMATION CONTACT:**

Quyen Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Room 5324, Silver Spring, MD 20993-0002, 301-796-2771, *[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 ZYCUBO (copper histidinate), manufactured by Sentynl Therapeutics Inc., meets the criteria for a priority review voucher. ZYCUBO (copper histidinate) injection is indicated for treatment of Menkes disease in pediatric patients.

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 ZYCUBO (copper histidinate), go to the “ *Drugs@FDA* ” website at *https://www.accessdata.fda.gov/scripts/cder/daf.*

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.