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FDA has accepted for review Pfizer’s new drug application for its modified-release formulation of tofacitinib citrate tablets (Xeljanz).
Pfizer announced that its new drug application (NDA) for its once-daily modified-release 11 mg tofacitinib citrate tablets (Xeljanz) has been accepted for review by FDA. Xeljanz is indicated for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate. The drug is approved in 40 countries worldwide. The anticipated Prescription Drug User Fee Act (PDUFA) action date given by FDA is February 2016 for this NDA.
The NDA for Pfizer’s new once-daily formulation is based on data from a clinical study designed to show equivalence with the twice-daily 5 mg tablets. Rory O’Connor, MD, senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer, said in a press statement, that approval of the new formulation “would bring us one step closer to offering the first and only once-daily oral Janus kinase inhibitor treatment for those living with moderate to severe RA who have had an inadequate response or intolerance to methotrexate.”