Zydus Cadila gets tentative USFDA nod for generic drug

NEW DELHI: Drug firm Zydus Cadila on Monday said it has received tentative approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat ulcerative colitis, in the American market.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for the product which is the generic version of Pfizer's Xeljanz XR tablets, Zydus Cadila said in a statement.

The medication is recommended for the once-daily treatment of adult patients with moderate to severe active ulcerative colitis (UC).


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

The group now has 308 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04, it added.