Cipla gets approval for first generic Proventil HFA inhaler

Drug major Cipla has got a green signal by the US Food and Drug Administration for the first generic Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation.

“The FDA accepts the growing demand for albuterol products during the novel coronavirus pandemic,” states
D FDA Commissioner Stephen M. Hahn, M.D.

Proventil HFA inhaler is used for treating or preventing bronchospasm in a human body for four years of age and older who have reversible resistant airway issues, as well as the prevention of exercise-induced bronchospasm in this age group.

“This development repeats our commitment tonourishing our respiratory franchise and will also 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,”

shares Umang Vohra, MD, and Global CEO, Cipla.

The company is planning shipments in a staggered manner, he added saying, “We are also ensuring that we do our bit by donating the product in this time of need.”

According to IQVIA, Proventil HFA Inhalation Aerosol and its approved generic Cipla HFA equivalent had US sales of approximately $153 million for the 12 months ending February 2020. The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of nearly $2.8 billion for the 12 months ending February 2020.




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