Cipla receives final approval for generic version of Proventil HFA inhalation aerosol

Cipla Limited has received final approval for its abbreviated new drug application (ANDA) for Albuterol Sulfate inhalation aerosol 90 mcg (base)/actuation from the USFDA. Cipla’s Albuterol Sulfate inhalation aerosol 90 mcg (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, Proventil HFA inhalation aerosol and its authorized generic equivalent had US sales of approximately USD 153 million for the 12-month period ending February 2020. The entire Albuterol Sulfate HFA inhalation aerosol market had US sales of approximately USD 2.8 billion for the 12-month period ending February 2020.

Umang Vohra
MD and Global CEO,
Cipla Limited

“We are pleased to receive the final approval for generic Albuterol MDI from the USFDA. This further strengthens our presence in the US market. Albuterol is the first generic metered dose inhaler of Proventil HFA inhalation aerosol ever approved by FDA in the US and Cipla’s first device-based inhalation product in the market. This development reiterates our commitment to strengthening of our respiratory franchise, and will further solidify our position as a lung leader globally. We will continue to build on our portfolio of drug-device combinations in the respiratory space to serve the unmet needs of our patients across markets. We are planning shipments in a staggered manner. We are also ensuring that we do our bit by donating the product in this time of need.”

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