FDA actions, week of November 9, 2026: 1 approval, 1 rule
The FDA published 2 actions so far in the week of November 9 to 15, 2026: 1 approval announcement and 1 final rule in the Federal Register.
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This page updates as the week's records arrive. The week ends on Sunday, November 15, 2026.
Approvals
- FDA approves Sunharbo for secondary stroke prevention. The FDA approved Sunharbo (asundexian) 50 mg tablets on November 09, 2026 for adults at high risk of stroke after a mild-to-moderate non-cardioembolic ischemic stroke or high-risk TIA. The OCEANIC-STROKE phase 3 study enrolled 12,327 participants and found Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26 % compared to placebo over a median treatment of 14.2 months. Source: FDA approval page, November 9, 2026.
Final rules
- FDA partially grants petition to remove methylene chloride as color additive diluent. The order removes a solvent used as a diluent in inks for marking fruit and vegetables, effective January 11, 2027. Requests to remove ethylene dichloride and trichloroethylene from extraction solvents for annatto, paprika, and turmeric were denied because residues would be impurities not covered by the Delaney Clause. Source: Federal Register rule, November 10, 2026.
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