Lupin gets US FDA approval for generic Uloric tablets

Lupin gets US FDA approval for generic Uloric tablets

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for febuxostat tablets, 40 mg and 80 mg, to market a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc. The product will be manufactured at Lupin’s Pithampur facility in India.

 

Febuxostat tablets, 40 mg and 80 mg, are indicated for the chronic management of hyperuricemia in adult patients with gout 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.

 

Febuxostat tablets (RLD Uloric) had estimated annual sales of USD 27 million in the US (IQVIA MAT November 2023).

 

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!