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Aurobindo Pharma Inhaler Gets Key USFDA Green Light

15 Sep

Summary

Aurobindo Pharma's first metered-dose inhaler received USFDA final approval.
The approval is for Beclomethasone Dipropionate HFA Inhalation Aerosol.
The inhaler is indicated for maintenance treatment of asthma in patients aged five years.

Aurobindo Pharma has achieved a significant milestone with the USFDA granting final approval for its inaugural metered-dose inhaler. The product, Beclomethasone Dipropionate HFA Inhalation Aerosol, will be available in 40 mcg and 80 mcg strengths. This generic equivalent to Teva's QVAR Inhalation Aerosol is manufactured at Aurobindo's facility in Raleigh, North Carolina.

The approval signifies Aurobindo's strategic move into complex respiratory therapies, enhancing its capabilities within the inhalation segment. The company aims to drive differentiated growth in the US market with such advanced therapies.

This respiratory inhaler is prescribed for the maintenance treatment of asthma as a prophylactic measure for patients aged five years and older. The US market for the approved product and related versions of the reference product was valued at approximately $301 million for the twelve months ending July 2026.

Aurobindo Pharma anticipates launching the product in the upcoming quarters. This latest clearance brings the company's total cumulative USFDA ANDA approvals to 596, reinforcing its diverse portfolio of specialized products.

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