This PDF is the current document as it appeared on Public Inspection on 04/24/2017 at 08:45 am.
Food and Drug Administration, HHS.
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), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), 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 EMFLAZA (deflazacort) oral tablets, and oral suspension manufactured by Marathon Pharmaceuticals, LLC, meets the criteria for a priority review voucher.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842, FAX: 301-796-9858, email: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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), which was added by FDASIA, FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that Emflaza (deflazacort) manufactured by Marathon Pharmaceuticals, LLC, meets the criteria for a priority review voucher. EMFLAZA (deflazacort) is indicated for the treatment of Duchenne Muscular Dystrophy in patients 5 years of age and older.
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 EMFLAZA (deflazacort), go to the “Drugs@FDA” Web site at https://www.accessdata.fda.gov/scripts/cder/daf/.Start Signature
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08309 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P