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FDA Medication Tracker

← All approvals · Immune & inflammatory · 2024

Ohtuvayre (ensifentrine)

The FDA approved Ohtuvayre (ensifentrine) on June 26, 2024 to treat chronic obstructive pulmonary disease.
Brand name
Ohtuvayre
Generic name
ensifentrine
FDA approval date
June 26, 2024
Approved use (FDA wording)
To treat chronic obstructive pulmonary disease
Company
Msd
Application
NDA217389
Dosage form / route
SUSPENSION · INHALATION
Drug class (EPC)
Phosphodiesterase 3 Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Immune & inflammatory

Indications and usage, from the FDA label

OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.