Zydus Lifesciences bags USFDA nod for Febuxostat Tablets to treat high uric acid
Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Febuxostat Tablets, 40 mg and 80 mg (USRLD: Uloric Tablets).
Febuxostat tablets are indicated to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.
Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022). The group now has 340 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.
Read also: Zydus Pharma (USA) unveils Topiramate ER Capsules for epilepsy
Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
The group has manufacturing capabilities across the entire pharmaceutical value chain: including formulations, APIs, vaccines, biosimilars, complex products (transdermals, topical etc.), animal health products and wellness products.
