Lupin receives USFDA approval for Albuterol Sulfate Inhalation Aerosol

Lupin announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation, a generic version of ProAir HFA. Lupin's generic Albuterol Sulphate MDI will be manufactured at its Indore (Unit III) facility in India.

ProAir HFA (Albuterol Sulfate Inhalation Aerosol) is the registered trademark of Teva Branded Pharmaceutical Products R&D, Inc. (Teva) and is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

The total Albuterol Sulfate Inhalation Aerosol market had U.S. sales of approximately US$2.9 billion, of which the ProAir HFA market accounted for US$1.3 billion (IQVIA MAT June 2020).

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