Opportunity
Federal Register #Docket No. FDA-2026-N-3466
FDA Notice: Approval of MRESVIA RSV Vaccine and Market Status of REVIA Tablets
Buyer
Food and Drug Administration
Posted
April 16, 2026
Identifier
Docket No. FDA-2026-N-3466
This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces regulatory actions related to pharmaceutical products: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - FDA (regulatory authority; no commercial OEMs or vendors specified) - Products/Services Mentioned: - MRESVIA (Respiratory Syncytial Virus Vaccine) - Approved via redemption of a Rare Pediatric Disease Priority Review Voucher - No purchase quantities or part numbers provided - REVIA (naltrexone hydrochloride) tablets, 50 mg - Part Number: NDA 018932 - Determined not withdrawn for safety or effectiveness reasons, allowing continued approval of generics - Unique or Notable Requirements: - Notice is informational only; no procurement or solicitation of goods/services - Highlights regulatory approval and continued market availability of specific pharmaceuticals - Key Locations: - Center for Biologics Evaluation and Research, FDA - Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Ave., Bldg. 51, Rm. 6281, Silver Spring, MD 20993-0002 - Department of Health and Human Services (federal office) - No contract value, period of performance, or procurement action is associated with this notice.
Description
The Food and Drug Administration (FDA) announces the approval of MRESVIA, a Respiratory Syncytial Virus Vaccine, which redeems a rare pediatric disease priority review voucher. This approval, dated June 12, 2025, meets the criteria set by the Federal Food, Drug, and Cosmetic Act for such vouchers. The notice serves to inform the public of the issuance of this priority review voucher and the approval of the product under this program. The FDA provides further information and resources related to the Rare Pediatric Disease Priority Review Voucher Program and the approved product.