April 25, 2018 / 1:33 PM / 7 months ago

BRIEF-FDA Accepts For Review Sanofi's Supplemental Biologics License Application

April 25 (Reuters) - SANOFI SA:

* FDA ACCEPTS FOR REVIEW SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR 0.5 ML DOSE OF FLUZONE® QUADRIVALENT (INFLUENZA VACCINE) IN CHILDREN 6-35 MONTHS OF AGE

* DETAILED RESULTS FROM PHASE IV, RANDOMIZED, OBSERVER-BLINDED, CONTROLLED, MULTICENTER STUDY TO BE PRESENTED LATER THIS YEAR

* PER THE PRESCRIPTION DRUG USER FEE ACT, THE TARGET ACTION DATE IS JANUARY 28, 2019

* IF APPROVED, PHYSICIANS WILL BE ABLE TO RESERVE VACCINE FOR YOUNG CHILDREN FOR 2019-2020 FLU SEASON Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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