Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Their strong recommendation is based on moderate certainty evidence that it improves survival and reduces the need for ventilation
Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength
XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor
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