Amneal Marks Respiratory Milestone With FDA Tentative Approval For Beclomethasone Dipropionate Its Generic QVAR Inhalation Aerosol

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol in 40 mcg and 80 mcg strengths per actuation. The product is the generic equivalent of QVAR® (beclomethasone dipropionate HFA), marketed by IVAX LLC, a subsidiary of Teva Group.

Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged five years and older. It is not intended for acute bronchospasm relief. The most common side effects observed include headache, sore throat, upper respiratory infection, rhinitis, sinusitis, and worsening asthma symptoms.

“Our first metered-dose inhalation product is a landmark achievement for Amneal,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “This milestone reflects years of dedicated work at our state-of-the-art respiratory facility and marks the beginning of an important new therapeutic category for Amneal. With additional inhalation programs advancing, we are well positioned to drive a new growth vector within our Affordable Medicines segment.”

This tentative approval marks Amneal’s first metered-dose inhaler (MDI) product, representing a major milestone in the company’s expansion into complex respiratory therapies. According to IQVIA® data, U.S. annual sales of beclomethasone dipropionate HFA inhalation aerosol reached approximately $329 million for the 12 months ending August 2025, signaling a substantial market opportunity for Amneal upon final FDA approval.