FDA Extends Action Date For Tofacitinib New Drug Application By Three Months

August 24, 2012

The U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for tofacitinib (Pfizer), an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis which has also been studied as a potential agent for psoriasis. The FDA determined that Pfizer's recent submission of additional data analyses constitutes a major amendment to the application and will thus require additional time to review all data. In addition, the FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) date of November 21, 2012.

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