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FDA Approves Generic Version of Proventil HFA Metered Dose Inhaler

Demand for albuterol sulfate products has increased amid COVID-19 pandemic

WEDNESDAY, April 8, 2020 (HealthDay News) -- The first generic of a commonly used albuterol sulfate inhaler has been approved for the prevention or treatment of bronchospasm in patients with obstructive airway disease, the U.S. Food and Drug Administration announced today.

A generic version of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/inhalation, has been approved for treatment and prevention of bronchospasm and for prevention of exercise-induced bronchospasm in patients aged 4 years and older. In an agency news release, FDA Commissioner Stephen M. Hahn, M.D., acknowledged that demand has increased for albuterol sulfate products during the novel coronavirus pandemic.

The most commonly reported side effects associated with the Albuterol Sulfate Metered Dose Inhaler, 90 mcg/inhalation, include upper respiratory tract infection, rhinitis, nausea, vomiting, tachycardia, tremor, and nervousness.

Approval of the generic albuterol sulfate inhalation aerosol was granted to Cipla Limited.

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