FDA Approves Generic Tablets for Treatment of Gout

Novadoz Pharmaceuticals, who markets the product, has commenced shipping of the drug, available in bottles of 30 tablets.

Officials with the FDA have approved Novadoz Pharmaceuticals’ generic version of febuxostat (Uloric,Takeda). According to Novadoz, its Febuxostat 40mg and 80mg tablets products have commenced shipping bottles with 30 tablets.1

Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia, or elevated levels of uric acid, in adult patients with gout who have a poor response to a maximally titrated dose of allopurinol (Zyolprim, Mylan), patients intolerant to allopurinol, and for treatment where allopurinol is not advisable. 1

According to the Arthritis Foundation, gout is a form of inflammatory arthritis that develops in some patients who have high levels of uric acid in the blood. The acid can form needle-like crystals in a joint and cause sudden, severe episodes of pain, tenderness, redness, warmth, and swelling.2

REFERENCES

  • Novadoz Pharmaceuticals/MSN Labs is granted FDA Approval of generic Febuxostat Tablets, begins immediate shipping [press release]. Published December 30, 2019. https://www.prnewswire.com/news-releases/novadoz-pharmaceuticalsmsn-labs-is-granted-fda-approval-of-generic-febuxostat-tablets-begins-immediate-shipping-300979945.html. Accessed January 2, 2020.
  • What is Gout? Arthritis Foundation. https://www.arthritis.org/about-arthritis/types/gout/what-is-gout.php. Accessed January 2, 2020.