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Drug firm Zydus Cadila on Monday said it has received final approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat rheumatoid arthritis, in the American market.
The company said it has received approval from the US Food and Drug Administration (USFDA) for the drug in 11 mg and 22 mg strengths.
Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and thus holds 180-day exclusivity on this strength, the company said in a statement.
Also read: Cadila inks pact with Italian firm to launch generic product in US
According to IQVIA data, Tofacitinib extended-release tablets had annual sales of around $2,082 million in the US for the year ending June 2021.
Zydus said it would produce the drug at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
The Zydus group now has 321 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in 2003-04, it added.
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