In the United States, BREO ELLIPTA is not proposed for the relief of acute bronchospasm or for the treatment of asthma. GSK and Theravance are reviewing the strategy for a future US filing for asthma.

Following submission of a supplemental new drug application (sNDA) to the FDA, Breo Ellipta has been approved for the once-daily treatment of asthma in patients aged 18 years and older.

* 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 ...

Relvar(TM) and Breo(TM) Proposed as Brand Names for FF/VI in EU and US; New Dry Powder Inhaler Proposed to be Named Ellipta(TM) LONDON and SOUTH SAN FRANCISCO, Calif., Jul 13, 2012 ...