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BRIEF-U.S. FDA extends review period for Baricitinib, an investigational rheumatoid arthritis treatment
January 13, 2017 / 9:59 PM / 7 months ago

BRIEF-U.S. FDA extends review period for Baricitinib, an investigational rheumatoid arthritis treatment

Jan 13 (Reuters) - Incyte Corp

* U.S. FDA extends review period for baricitinib, an investigational rheumatoid arthritis treatment

* Incyte Corp says delay does not affect Lilly's previously-issued financial guidance for 2017

* Incyte - FDA extended action date to allow time to review additional data analyses recently submitted by Lilly in response to FDA's information requests

* Incyte- Submission of additional information was determined by FDA to constitute major amendment to NDA, resulting in extension of PDUFA date by 3 months Source text for Eikon: Further company coverage:

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