Zydus Cadila gets tentative USFDA approval for Tofacitinib ER Tablets
Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company has received tentative approval from the United States Food & Drug Administration (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.
Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.