Zydus Cadila gets USFDA nod for Tofacitinib ER tablets

Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company has received final approval from the United States Food & Drug Administration (USFDA) to market Tofacitinib extended-release tablets, 11 mg and 22 mg in the United States (ANDA-214264 and US RLD: XELJANZ XR).

Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength, the company said in a release.

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

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

Read also: First: Zydus Cadila needle-free COVID vaccine gets DCGI nod, PM Modi says momentous feat