Federal Register #Docket No. FDA-2025-P-4151

FDA Regulatory Notice on REVIA, Pediatric Vaccine Approvals, and HRSA Data Collection

This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, provides regulatory updates and program information: - FDA confirms that REVIA (Naltrexone Hydrochloride) Tablets, 50 mg, was not withdrawn for safety or effectiveness reasons - Allows continued approval of generic drug applications referencing REVIA - Teva Women's Health, Inc. is the original NDA holder (NDA 018932) - FDA announces rare pediatric disease priority review voucher approvals for two vaccines: - MRESVIA (Respiratory Syncytial Virus Vaccine) - MNEXSPIKE (COVID19 Vaccine, mRNA) - Health Resources and Services Administration (HRSA) will collect performance data for the Transforming Pediatrics for Early Childhood Program - No procurement of products or services is requested; this is an administrative and regulatory notice - Key OEMs mentioned: - Teva Women's Health, Inc. (REVIA) - (Implied) Manufacturers of MRESVIA and MNEXSPIKE vaccines - Notable requirements: - Regulatory determination enables continued generic competition for REVIA - HRSA-funded organizations must report pediatric program performance data

Description

The Food and Drug Administration (FDA) has determined that REVIA (naltrexone hydrochloride) tablets, 50 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) referring to this product and will continue to approve ANDAs that meet legal and regulatory requirements. The notice confirms the product's status in the FDA's Orange Book and allows continued generic drug approvals referencing REVIA.

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