Dr. Reddy’s Laboratories announces the launch of Febuxostat Tablets in the U.S. Market

Dr. Reddy's Laboratories announces the launch of Febuxostat Tablets in the U.S. Market
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Hyderabad, India and Princeton, NJ, USA –  Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as “Dr. Reddy’s” today announced the launch of Febuxostat Tablets, a therapeutic equivalent generic version of Uloric (Febuxostat) Tablets approved by the U.S. Food and Drug Administration (USFDA).

The Uloric brand and generic had U.S. sales of approximately $108 million MAT for the most recent twelve months ending in October 2020 according to IQVIA Health*.

Dr. Reddy’s Febuxostat Tablets are available in 40 mg and 80 mg strengths in bottle count sizes of 30 tablets.

Please see the full prescribing information including boxed warning.

https://www.drreddys.com/pi/febuxostat_tablets.pdf

WARNING: CARDIOVASCULAR DEATH

Gout patients with established cardiovascular (CV) disease treated with Febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1)].

Consider the risks and benefits of Febuxostat when deciding to prescribe or continue patients on Febuxostat. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage (1)].

Uloric is a trademark of TEIJIN KABUSHIKI KAISHA (TEIJIN LIMITED)

*IQVIA Retail and Non-Retail MAT October 2020.

RDY-0121-323