Pfizer Announces FDA Approval Of Supplemental Application To Expand XELJANZ® (tofacitinib Citrate) Labeling To Include Additional Patient-Reported Outcomes Data For Adults With Moderately To Severely Active Rheumatoid Arthritis
DISCLOSURE NOTICE: The information contained in this release is as of November 18, 2013. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about XELJANZ (tofacitinib citrate), including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, uncertainties related to the extent of market acceptance in the U.S.; whether and when the FDA will assess the benefit: risk profile of the 10 mg twice-daily dose and the impact of XELJANZ on the inhibition of structural damage; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2012, and in its reports on Form 10-Q and Form 8-K.
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