Regulatory briefs from GSK/Theravance, Allergan and Mylan

19 December 2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX0 have submitted a New Drug Application to the US Food and Drug Administration for once-daily (LAMA/LABA) combination medicine, umeclidinium bromide + vilanterol (62.5/25mcg and 125/25mcg), administered using the Ellipta inhaler for chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The proposed proprietary name of the drug is Anoro Ellipta.

The companies also asked the European Medicines Agency for approval of the same drug, to be known in Europe as Relvar, for treatment of COPD patients as well as asthma patients aged 12 years and older.

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