2019-06145. Issuance of Priority Review Voucher; Material Threat Medical Countermeasure 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 the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. On July 13, 2018, FDA determined that TPOXX (tecovirimat), manufactured by SIGA Technologies, Inc., meets the criteria for a priority review voucher.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Sadove, Office of Counterterrorism and Emerging Threats, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8510.

SUPPLEMENTARY INFORMATION:

FDA is announcing the issuance of a priority review voucher to the sponsor of an approved material threat MCM product application. Under section 565A of the FD&C Act (21 U.S.C. 360bbb-4a), which was added by the Cures Act, FDA will award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA has determined that TPOXX (tecovirimat), manufactured by SIGA Technologies, Inc., meets the criteria for a priority review voucher. TPOXX (tecovirimat) is indicated to treat human smallpox disease in adults and pediatric patients weighing at least 13 kilograms.

For further information about the material threat MCM Priority Review Voucher Program and for a link to the full text of section 565A of the FD&C Act, go to https://www.fda.gov/​EmergencyPreparedness/​Counterterrorism/​MedicalCountermeasures/​MCMLegalRegulatoryandPolicyFramework/​ucm566498.htm#prv. For further information about TPOXX (tecovirimat), go to the “Drugs@FDA” website at https://www.accessdata.fda.gov/​scripts/​cder/​daf/​.

Dated: March 26, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.