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.
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.