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Ohtuvayre FDA Approval History

FDA Approved: Yes (First approved June 26, 2024)
Brand name: Ohtuvayre
Generic name: ensifentrine
Dosage form: Inhalation Suspension
Company: Verona Pharma plc
Treatment for: COPD, Maintenance

Ohtuvayre (ensifentrine) is a selective dual inhibitor of the enzymes phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

Development timeline for Ohtuvayre

DateArticle
Jun 26, 2024Approval FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Sep 11, 2023Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD
Jun 27, 2023Verona Pharma Submits New Drug Application to US FDA for Ensifentrine for the Maintenance Treatment of COPD
Dec 17, 2018Verona Pharma Initiates Phase 2 Clinical Trial to Evaluate Dry Powder Inhaler Formulation of RPL554 for Maintenance Treatment of COPD

Further information

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