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Pfizer Says FDA Extends Action Date For Tofacitinib NDA By 3 Months

Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration, or FDA, has extended the action date by three months for the New Drug Application, or NDA, for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis, or RA.

The company stated that if approved, tofacitinib would be the first RA treatment in a new class of medicines known as Janus kinase inhibitors and the first new oral disease-modifying antirheumatic drug for RA in more than 10 years.

FDA determined that additional data analyses recently submitted by Pfizer constitute a major amendment to the application and will require additional time to review. FDA has not asked that Pfizer complete any new studies. FDA has provided an anticipated Prescription Drug User Fee Act date of November 21, 2012.

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