Supplemental NDA submitted for Aerospan for asthma

Acton announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for its new asthma product, Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol. This sNDA is a Manufacturing Supplement to the previously approved NDA. Acton has filed this Supplement to establish procedures to bring previously the approved Aerospan Inhalation Aerosol to full commercial scale.

Aerospan is the first hydrofluoroalkane (HFA) propelled, orally inhaled corticosteroid to incorporate an integrated spacer device that assists patients in delivering their medication to the lung; it is indicated for the maintenance treatment of asthma as prophylactic therapy in patients ≥6 years of age.

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