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Anoro Ellipta Approval History

  • FDA approved: Yes (First approved December 18th, 2013)
  • Brand name: Anoro Ellipta
  • Generic name: umeclidinium bromide and vilanterol
  • Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
  • 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.

FDA Approval History 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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