Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Aventis Pharma’s Arava tablets.
Leflunomide tablets, belonging to a class of medications called disease modifying anti-rheumatic drugs, is used of the treatment of rheumatoid arthritis.
Zydus said that its tablets will be sold in doses of 10 mg and 20 mg and will be manufactured at Zydus’ facility in Baddi, Himachal Pradesh.
With the latest nod, Zydus has so far received 263 approvals and filed over 350 applications for sales of its generic drugs.
Rheumatoid arthritis is a long-term, progressive, and disabling autoimmune disease. It causes inflammation, swelling, and pain in and around the joints and other body organs.
Headquartered in Ahmedabad, Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and in the United States and Brazil.