Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg, a generic equivalent of QVAR® Inhalation Aerosol 40 mcg and 80 mcg, marketed by Teva Branded Pharmaceutical Products R&D LLC.
This represents Aurobindo's first metered-dose inhaler (MDI) product, marking a significant milestone in the Company's expansion into complex respiratory therapies and strengthening its capabilities in the inhalation segment. The product will be manufactured at Aurobindo Pharma's Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. The product is expected to be launched in upcoming quarters.
The US market for the approved product and newer versions of the reference product, QVAR® RediHaler, was estimated at US$301 million for the twelve months ended July 2026, according to IQVIA. |