ANDA 217298, held by Msn. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 217298 (Tofacitinib Citrate), held by Msn, was first approved by FDA on Jun 3, 2026, with 0 approved supplements and 0 published complete response letters.
Tofacitinib oral solution is Janus kinase (JAK) inhibitors. Tofacitinib oral solution is indicated for the treatment of pediatric patients 2 years of age and older with: Active psoriatic arthritis PsA, who have had an inadequate response or intolerance to one or more TNF blockers. Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofacitinib oral solution for PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.2, 1.4 ) 1.2 Psoriatic Arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tofacitinib CitrateEQ 1MG BASE/ML · solution;oral | Tofacitinib Citrate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
