Novadoz Pharmaceuticals receives FDA go-ahead for Febuxostat generic

US-based Novadoz Pharmaceuticals has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.

Approval of Febuxostat generic

Novodoz Pharmaceuticals is the sales and marketing subsidiary of MSN Labs – a leader in the production and supply of APIs (active pharmaceutical ingredients) to numerous US generic drug companies. They are also one of the leading holders of active DMFs (Drug Master Files).

The approved product is AB rated to the brand Uloric©, marketed by Takeda Pharmaceuticals America, Inc., and shipping of the product that is available in bottles of 30 tablets has already commenced. 

Febuxostat brand and generic sales are trending over $430 million over the last 12 months, according to recent published sales data.

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

Seshu Akula, Novadoz President North America Generics, stated: “FDA approval of Febuxostat is the 12th product introduction for the Novadoz label in the first 20 months of our US commercialisation. Novadoz and the MSN organisations 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 number one 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.” 

Tom DeStefano, Novadoz Vice President Sales & Marketing, said “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 fulfilment. The FDA approval of Febuxostat furthers our emergence as a future leader in the generic pharma industry.”   

MSN Labs is engaged in the development and manufacturing of APIs (active pharmaceutical ingredients), KSMs (key starting materials) and product intermediates. MSN is the global leader in this category. Additionally, the company also manufactures oral solids, liquids and specialty injectable products in sixty-five markets throughout the world, doing business in the US as Novadoz Pharmaceuticals.

Send this to a friend