FDA Approves PRIORIX Labeling Supplement on November 14, Adding Immunosuppressive-Treatment Contraindication Information
On November 14, 2025, the U.S. Food and Drug Administration (FDA) issued a supplement approval letter to GlaxoSmithKline Biologicals SA for PRIORIX, a measles, mumps, and rubella vaccine, live, under Biologics License Application STN BL 125748/119. The FDA had received the supplement request on May 15, 2025.
The revision covers the PRIORIX package insert and carton label. It adds immunosuppressive-treatment-related information to Contraindications (Section 4.2) and Drug Interactions (Section 7.1), adds chronic cutaneous granulomas with rubella vaccine virus detected by biopsy to Adverse Reactions (Section 6.2), and adds a case of congenital rubella syndrome to Use in Specific Populations (Section 8.1), along with minor associated labeling changes.
In the approval letter, the FDA directed the company to submit the final content of labeling in Structured Product Labeling format through the FDA automated drug registration and listing system as soon as possible, and no later than 14 days from the date of the letter. The approval is a labeling update and does not add a new indication.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: PRIORIX麻疹、腮腺炎和风疹活疫苗产品包装与药瓶。照片：Dctrzl，CC BY-SA 4.0，经 Wikimedia Commons / PRIORIX measles, mumps and rubella vaccine packaging and vial. Photo: Dctrzl, CC BY-SA 4.0, via Wikimedia Commons
