Aurobindo Pharma Receives USFDA Final Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol
Aurobindo Pharma received USFDA final approval for Beclomethasone Dipropionate HFA Inhalation Aerosol (40 mcg and 80 mcg). This is the company's first MDI product, strengthening its respiratory therapy portfolio. The US market for the product was estimated at $301 million. Production will be at its North Carolina facility.
The approval of a new product, especially a first-in-class MDI for the company, is significant. The market size of $301 million indicates potential for revenue growth, though its immediate impact will depend on launch timelines and market penetration.
The USFDA approval for a new inhalation aerosol product is a positive development, expanding the company's product portfolio and market presence in a key therapeutic area.
Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg. This product is a generic equivalent of Teva Branded Pharmaceutical Products R&D LLC's QVAR® Inhalation Aerosol.
This approval marks a significant milestone for Aurobindo Pharma as it represents their first metered-dose inhaler (MDI) product, expanding their presence in complex respiratory therapies and strengthening their inhalation segment capabilities. The product will be manufactured at Aurobindo Pharma's facility in Raleigh, North Carolina, owned by its subsidiary Aurolife Pharma LLC, and is anticipated to be launched in the upcoming quarters.
The US market for the approved product and its reference product, QVAR® Redi Haler, was valued at approximately US$301 million for the twelve months ending July 2026, according to IQVIA. This approval brings Aurobindo Pharma's cumulative USFDA ANDA approvals to 596, with 571 final and 25 tentative approvals.
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma in patients aged 5 years and older, as a prophylactic therapy. It is particularly useful for asthma patients requiring systemic corticosteroids, as it may reduce or eliminate the need for such treatments.
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