Zydus Cadila gets USFDA nod for Tofacitinib ER Tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

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USFDA
Picture: Pixabay

Last Updated on August 25, 2021 by The Health Master

Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market tofacitinib extended release tablets, 11 mg and 22 mg in the United States.

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 United States 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.

The group now has 321 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

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