GlaxoSmithKline Seeks US Regulatory Approval for Shingles Vaccine
October 24 2016 - 2:50AM
Dow Jones News
By Tapan Panchal
LONDON--GlaxoSmithKline PLC (GSK.LN) said Monday that it has
sought U.S. Food and Drug Administration approval for a new vaccine
for the prevention of shingles, a viral disease characterized by a
skin rash with blisters involving a limited area.
The pharmaceutical company has submitted a biologics license
application for Shingrix vaccine to the regulator.
The company said regulatory submissions for the vaccine in the
European Union and Canada are on track for 2016 and planned for
Japan in 2017. The vaccine isn't currently approved for use
anywhere in the world.
-Write to Tapan Panchal at tapan.panchal@wsj.com
(END) Dow Jones Newswires
October 24, 2016 02:35 ET (06:35 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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