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Anoro Ellipta Approval History

FDA Approved: Yes (First approved December 18, 2013)
Brand name: Anoro Ellipta
Generic name: umeclidinium bromide and vilanterol
Company: GlaxoSmithKline
Treatment for: COPD

Anoro Ellipta (umeclidinium bromide and vilanterol) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA) combination for the treatment of COPD.

Development History and FDA Approval Process for Anoro Ellipta

DateArticle
Dec 18, 2013Approval FDA Approves Anoro Ellipta to Treat Chronic Obstructive Pulmonary Disease
Sep 10, 2013FDA Advisory Committee to Review Anoro Ellipta NDA
Sep 10, 2013FDA Advisory Committee Recommends Approval in U.S. of Umeclidinium/Vilanterol for the Treatment of COPD
Aug  2, 2013Theravance Announces FDA Advisory Committee to Review Anoro Ellipta (UMEC/VI) for COPD
Feb 19, 2013GSK and Theravance Announce FDA Acceptance of New Drug Application Submission in the US for Anoro Ellipta for COPD

Further information

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