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The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib; Pfizer) to eliminate the requirement for the approved Risk Evaluation and Mitigation Strategy (REMS) assessment.
The REMS for Xeljanz 5mg tablets was initially approved on November 6, 2012 with the most recent modification approved on June 19, 2015. The REMS consisted of a communication plan and a timetable for submission of assessments of the REMS. Pfizer’s proposed modifications included the elimination of the communication plan thus releasing the requirement for a REMS.
RELATED: FDA to Review New Xeljanz Formulation for RA
In the FDA’s REMS Modification Notification Letter from January 2016, the Agency decided a communication plan was no longer necessary to include as part of the approved REMS because it has been completed. The most recent assessment showed that the communication plan achieved its goals.
Xeljanz, a janus kinase (JAK) inhibitor, is currently indicated for moderately-to-severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX); may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).
Xeljanz is available as 5mg tablets in 28-, 60-, and 180-count bottles.
For more information call (800) 438-1985 or visit Xeljanz.com.
