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As of Nov 15, 2026, ANDA 219530 (Tofacitinib Citrate), held by Macleods Pharms, was first approved by FDA on Jun 3, 2026, with 0 approved supplements and 0 published complete response letters.
First approved: Jun 3, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Tofacitinib tablets are Janus kinase (JAK) inhibitors.
Tofacitinib tablets are indicated for the treatment of adult patients with:
Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.
Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.
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
