Novadoz gets FDA nod for generic Uloric

Novadoz Pharmaceuticals has received the Food and Drug Administration’s approval for febuxostat tablets in dosage strengths of 40 mg and 80 mg. 

The product is the generic of Takeda’s Uloric. 

Novadoz has commenced shipping of the product, which is available in bottles of 30 tablets.

The Febuxostat brand and generics had a market value of over $430 million over the previous 12 months, according to recent published sales data.

"FDA approval of Febuxostat is the 12th product introduction for the Novadoz label in the first 20 months of our U.S. commercialization. Novadoz and the MSN organizations are committed to being part of Day 1 and Day 181 product launches, providing high value to our customers, and to the pharmacies and companies in their supply chain. Our vertical integration through MSN, the #1 API supplier in the world, continues to define our success now and in the future.  We expect continued success in 2020 with multiple product approvals, including several in the specialty oncology space." Seshu Akula, Novadoz president North America generics said.

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

"2019 had many successes in our first full year of operation.  We have gratitude for the customers that placed confidence in our ability to supply high volume and specialty products.  Our successful supply chain management ensures customers' on-time order fulfillment.  The FDA approval of febuxostat furthers our emergence as a future leader in the generic pharma industry," Tom DeStefano, Novadoz vice president sales and marketing said.