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Yupelri Approval History

FDA Approved: Yes (First approved November 9, 2018)
Brand name: Yupelri
Generic name: revefenacin
Dosage form: Inhalation Solution
Company: Theravance, Inc.
Treatment for: COPD

Yupelri (revefenacin) is a long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD).

Development History and FDA Approval Process for Yupelri

DateArticle
Nov  9, 2018Approval FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)
Oct 11, 2018Theravance Biopharma and Mylan Report Positive New Data from Multiple Studies of Yupelri (revefenacin) at the 2018 CHEST Annual Meeting
Sep 11, 2018Theravance Biopharma and Mylan to Report New Data from Phase 3 Studies of Yupelri (revefenacin) in Oral Presentation at European Respiratory Society International Congress 2018
Jan 29, 2018Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
Nov 13, 2017Theravance Biopharma and Mylan Submit NDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
Jul 19, 2017Theravance Biopharma and Mylan Announce Positive Results from 12-Month Phase 3 Safety Study of Revefenacin (TD-4208) in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Oct 20, 2016Theravance Biopharma and Mylan Announce Positive Results from Two Pivotal Phase 3 Studies of Revefenacin (TD-4208) for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Sep 14, 2015Theravance Biopharma and Mylan Initiate Phase 3 Program for Revefenacin (TD-4208) for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Further information

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