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Trelegy Ellipta FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved September 18, 2017)
Brand name: Trelegy Ellipta
Generic name: fluticasone furoate, umeclidinium and vilanterol
Dosage form: Inhalation Powder
Company: GlaxoSmithKline
Treatment for: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta2-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

Development timeline for Trelegy Ellipta

Sep  9, 2020Approval FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of Asthma
Apr 24, 2018Approval Once-Daily Trelegy Ellipta Gains Expanded Indication in the US for the Treatment of Patients with COPD
Sep 18, 2017Approval FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of COPD
Nov 21, 2016GSK Files Regulatory Submission in US for Once-Daily Closed Triple Combination Therapy FF/UMEC/VI for Patients with COPD

Further information

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