Zydus Cadila gets US FDA approval for Tofacitinib extended-release 22 mg tablet

Zydus Cadila has received the final approval from the US Food and Drug Administration (FDA) to market Tofacitinib extended-release tablets, 11 mg and 22 mg in the United States, a company statement said.

It also said that Zydus was the first ANDA filer on Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength.

Tofacitinib extended-release tablets had annual sales of approximately $2,082 million in the US for the year ending June 2021, according to IQVIA data. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, notified the statement.