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Zydus Cadila gets tentative US FDA nod for ulcerative colitis drug

The medication is suggested for the once-daily treatment of adult patients with moderate to severe active ulcerative colitis

Zydus Cadila has received tentative approval from the US health regulator to advertise Tofacitinib extended-release pills, used to treat ulcerative colitis, in the US market.

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

The medication is suggested 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 team currently has 308 approvals and has up to now filed over 390 abbreviated new drug applications (ANDAs) since the initiation of the filing procedure in 2003-04, it added.

 

PTI

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