Aurobindo Pharma Gets USFDA Approval for Beclomethasone Inhalation Aerosol

Aurobindo Pharma has received final approval from the USFDA for its Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg. This marks the company's first metered-dose inhaler (MDI) product, signifying an expansion into complex respiratory therapies. The product, a generic equivalent of QVAR® Inhalation Aerosol, will be manufactured at Aurobindo's US facility. The US market for this product category was estimated at $301 million. This approval brings Aurobindo's total USFDA ANDA approvals to 596, strengthening its portfolio of complex products. The product is indicated for the maintenance treatment of asthma in patients aged 5 years and older and is expected to launch in upcoming quarters.