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Breo Ellipta Approval History

  • FDA approved: Yes (First approved May 10th, 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 History and FDA Approval Process 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

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