Cipla receives USFDA final approval for generic Albuterol MDI

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, from the United States Food and Drug Administration (US FDA).

Cipla's Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp's Proventil HFA Inhalation Aerosol. It is used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

According to IQVIA (IMS Health): Proventil HFA Inhalation Aerosol and its authorized generic equivalent had US sales of approximately $153M for the 12-month period ending February 2020. The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of approximately $2.8 Billion for the 12-month period ending February 2020.

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