14 October 2015 - Pfizer Inc. announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of Xeljanz for the proposed indication.

For more details, go to: http://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_complete_response_letter_from_fda_for_oral_xeljanz_tofacitinib_citrate_supplemental_new_drug_application_for_moderate_to_severe_chronic_plaque_psoriasis