FDA Accepts New Drug Application for Tofacitinib
The FDA has accepted a new drug application for tofacitinib for review.
The US FDA has accepted a new drug application for tofacitinib, an experimental drug to treat moderately to severely active rheumatoid arthritis, for review.
The regulator set an action date for August 2012 to review Pfizer's investigational novel, oral JAK inhibitor.
Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan and applied for approval from the European Medicines Agency.
Pfizer president and general manager for specialty care and oncology Geno Germano said, "We are proud of the comprehensive Phase III clinical programme that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the
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