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BRIEF-Pfizer announces acceptance of regulatory submissions by U.S. FDA and European Medicines Agency for Sutent
May 31, 2017 / 12:38 PM / 2 months ago

BRIEF-Pfizer announces acceptance of regulatory submissions by U.S. FDA and European Medicines Agency for Sutent

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May 31 (Reuters) - Pfizer Inc

* Pfizer announces acceptance of regulatory submissions by U.S. FDA and European Medicines Agency for Sutent® (sunitinib) for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgery

* Pfizer Inc says applications seek to expand approved use of sutent based on data from phase 3 s-trac trial

* Prescription drug user fee act (pdufa) goal date for a decision by fda is in january 2018

* Pfizer Inc - ‍prescription drug user fee act (pdufa) goal date for a decision by fda is in january 2018​

* Pfizer Inc says adverse events seen in trial were consistent with known safety profile of suten

* Pfizer inc says no deaths occurred due to treatment

* Pfizer Inc - ‍european medicines agency (ema) has validated for review a type ii variation application for sutent in same patient population​ Source text for Eikon: Further company coverage:

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