Reuters: Regulatory News: FDA extends review for Pfizer arthritis drug by three months

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FDA extends review for Pfizer arthritis drug by three months Aug 21st 2012, 12:41 Tue Aug 21, 2012 8:41am EDT Aug 21 (Reuters) - The U.S. Food and Drug Administration has extended by three months its review for Pfizer Inc's experimental rheumatoid arthritis treatment tofacitinib, the company said on Tuesday. In July, Pfizer disclosed that the FDA sought a "routine" analysis of clinical trial data for the drug that could delay a decision by three months or more beyond the agency's Aug. 21 deadline. The FDA now views the additional analysis as a major amendment to Pfizer's application for approval, and set a new Nov. 21 deadline for reviewing the drug, the company said.

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