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Medical Devices / Submissions and Approvals

FDA Fast Tracks Combination Aerosol Treatment for Infants in Respiratory Distress

Oct. 10, 2016
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Windtree Therapeutics received a Fast Track designation from FDA for its Aerosurf (lucinactant for inhalation) aerosol treatment for premature infants with respiratory distress syndrome.

Aerosurf is a combination drug and device product that delivers aerosolized KL4 surfactant to premature infants, potentially reducing the need for invasive endotracheal intubation and mechanical ventilation to administer surfactant therapy. Aerosurf is currently being studied in an international Phase IIb clinical trial in premature infants 26- to 32-week gestational age.

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