Shots: The approval is based on a P-III study which includes 2 phases i.e., run-in & withdrawal phase evaluating efficacy & safety of tofacitinib (5mg tablet or mg/mL oral solution, […]readmore
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Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA […]readmore
The US FDA has approved 6 NDAs in Sept 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) […]readmore
Shots: The approval is based on P-III study including 2 phases assessing tofacitinib (5mg or 1mg/mL oral solution, bid) for 44wks. The 2phases includes an 18 wks. open-label, run-in phase […]readmore