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Manages active classical or definite rheumatoid arthritis (ARA criteria). NDA 18689, held by Legacy. Auranofin.
As of Nov 13, 2026, NDA 18689 (Ridaura), held by Legacy, was first approved by FDA on May 24, 1985, with 11 approved supplements and 0 published complete response letters.
First approved: May 24, 1985
Review: Priority
Supplements approved: 11
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, RIDAURA does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months.
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
