Aurobindo Pharma wins U.S. FDA approval for generic asthma inhaler

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Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg.

The product is a generic equivalent of QVAR Inhalation Aerosol, 40 mcg and 80 mcg, marketed by Teva Branded Pharmaceutical Products R&D LLC. It is Aurobindo’s first metered-dose inhaler and marks the company’s expansion into complex respiratory therapies. Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of asthma.

“Building on our leadership in generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the U.S. market,” Aurobindo said on Tuesday.

The product will be manufactured at subsidiary Aurolife Pharma’s Raleigh facility in North Carolina and expected to be launched in upcoming quarters. The U.S. market for the approved product and newer versions of the reference product was estimated at $301 million for the 12 months ended July 2026, Aurobindo said citing IQVIA numbers.

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