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Biotech / Medical : Incyte (INCY)

INCY 104.18

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From: scaram(o)uche	12/20/2011 11:08:35 AM
	of 3202

finance.yahoo.com Pfizer Announces FDA Acceptance For Review Of New Drug Application For Tofacitinib For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis Application Also Filed with Regulatory Authorities in Japan NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012 for the NDA. Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan. As disclosed in November, an application for tofacitinib for the treatment of adult patients with moderate-to-severe active RA is being reviewed by the European Medicines Agency. (snip)

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