Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market a generic asthma inhaler in the United States.
The approval covers Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg strengths. The product is a generic equivalent of QVAR Inhalation Aerosol, which is marketed by Teva Branded Pharmaceutical Products R&D LLC.
The inhaler is indicated for the maintenance treatment of asthma, making it part of the company’s expansion into respiratory therapies and complex drug-delivery products.
The product will be manufactured at Aurolife Pharma’s facility in Raleigh, North Carolina, a subsidiary of Aurobindo Pharma. The company is expected to launch the product in the upcoming quarters, subject to its commercial plans.
The FDA approval is also significant for Aurobindo Pharma because the Beclomethasone Dipropionate HFA Inhalation Aerosol is the company’s first metered-dose inhaler.
Metered-dose inhalers are designed to deliver a measured amount of medicine directly to the lungs and are widely used in respiratory conditions such as asthma.
The approval adds a new product category to Aurobindo Pharma’s U.S. portfolio and strengthens its presence in complex respiratory therapies.
The company’s move into inhalation products comes as pharmaceutical manufacturers continue expanding their generic portfolios beyond conventional oral medicines.