The U.S. Food and Drug Administration (FDA) granted a supplemental approval for Xeljanz XR (tofacitinib) on March 6, 2026. This approval pertains to an efficacy supplement (NDA 208246 S-27), with Pfizer as the sponsor.
What this means
This supplemental approval for Xeljanz XR indicates an update or expansion related to the drug's efficacy profile. While the specific indication or population for this efficacy supplement has not been detailed in the provided information, such approvals typically broaden the therapeutic scope or refine the understanding of a drug's benefits for patients.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for supplemental application NDA 208246 S-27 for Xeljanz XR (tofacitinib) was posted on March 6, 2026, on accessdata.fda.gov.