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Breo Ellipta FDA Approval History

FDA Approved: Yes (First approved May 10, 2013)
Brand name: Breo Ellipta
Generic name: fluticasone and vilanterol
Dosage form: Inhalation Powder
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: COPD, Asthma

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma.

Development timeline for Breo Ellipta

Apr 30, 2015Approval FDA Approves Breo Ellipta (fluticasone furoate/vilanterol) for Asthma
May 10, 2013Approval FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)
Apr 17, 2013FDA Advisory Committee Recommends Approval of Breo Ellipta for the Treatment of COPD
Sep 26, 2012GSK and Theravance Announce FDA Acceptance of FF/VI New Drug Application (NDA) Submission in the US for COPD

Further information

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