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BRIEF-GSK, Theravance submit sNDA to U.S. FDA for Breo Ellipta
June 30, 2014 / 12:10 PM / 3 years ago

BRIEF-GSK, Theravance submit sNDA to U.S. FDA for Breo Ellipta

June 30 (Reuters) - Glaxosmithkline Plc :

* GSK and Theravance announce submission to US regulatory authorities for Fluticasone Furoate/Vilanterol in asthma

* Today’s filing is based upon data generated from comprehensive clinical development programme for FF/VI in asthma

* sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using Ellipta dry powder inhaler Source text for Eikon: Further company coverage:

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