FDA gives Zydus Cadila tentative OK for generic Xeljanz
The Food and Drug Administration has given tentative approval to Zydus Cadila for tofacitinib extended-release tablets, in a dosage strength of 11 mg.
The product is the generic of Pfizer's Xeljanz XR tablets.
It is recommended for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis.