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Zurampic Approval History

FDA Approved: Yes (Discontinued) (First approved December 22, 2015)
Brand name: Zurampic
Generic name: lesinurad
Dosage form: Tablets
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Gout

Marketing Status: Discontinued

Zurampic (lesinurad) is a URAT1 inhibitor indicated for the combination treatment of hyperuricemia associated with gout.

On April 15, 2019, the FDA announced the discontinuation of Zurampic (lesinurad). The discontinuation was due to business reasons, and not due to any safety, efficacy or quality issues. The discontinuation was effective as of February 1, 2019.

Development History and FDA Approval Process for Zurampic

Dec 22, 2015Approval FDA Approves Zurampic (lesinurad) to Treat High Blood Uric Acid Levels Associated with Gout
Oct 23, 2015FDA Advisory Committee Recommends the Approval of Lesinurad for Gout Patients
Nov 16, 2014AstraZeneca Presents Data from Phase III Studies of Lesinurad in Combination with Allopurinol for Gout

Further information

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