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Duzallo Approval History

FDA Approved: Yes (Discontinued) (First approved August 18, 2017)
Brand name: Duzallo
Generic name: allopurinol and lesinurad
Dosage form: Tablets
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Gout

Marketing Status: Discontinued

Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination for the treatment of hyperuricemia in patients with uncontrolled gout.

On April 15, 2019, the FDA announced the discontinuation of Duzallo (allopurinol and 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 Duzallo

DateArticle
Aug 21, 2017Approval FDA Approves Duzallo (lesinurad and allopurinol) for Hyperuricemia in Patients with Uncontrolled Gout
Jan  4, 2017Ironwood Announces New Drug Application for Duzallo (Fixed-Dose Combination of Lesinurad and Allopurinol) Has Been Accepted for FDA Review

Further information

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