NEW YORK, N.Y., December 14 – Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) approved EUCRISA™ (crisaborole) ointment, 2%.
Please see full Prescribing Information at www.pfizer.com.
Pfizer will provide additional information on the FDA approval of EUCRISA in a separate press release, to be issued shortly.
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DISCLOSURE NOTICE: The information contained in this release is as of December 14, 2016. 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 an approval in the U.S. for EUCRISA (crisaborole) ointment 2%, including its potential benefits, and an approval in the U.S. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of EUCRISA; the uncertainties inherent in research and development, including the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when any applications for EUCRISA may be filed with regulatory authorities in any jurisdictions (other than the United States); whether and when regulatory authorities in any such other jurisdictions where applications may be filed may approve such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of EUCRISA; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.