Zydus Cadila receives USFDA tentative approval for Tofacitinib ER Tablets

Zydus Cadila has received tentative approval from the USFDA to market Tofacitinib Extended-Release Tablets, 11 mg (US RLD: Xeljanz XR Tablets). It is recommended for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC).

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 308 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

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