Amneal receives U.S. FDA tentative approval for beclomethasone dipropionate HFA inhalation aerosol
Thursday, October 30, 2025
Amneal Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol in 40 mcg and 80 mcg strengths per actuation. The product is a generic version of QVAR® (beclomethasone dipropionate HFA) inhalation aerosol, a registered trademark of IVAX LLC, part of the Teva Group.
Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid used for the maintenance treatment of asthma and as prophylactic therapy in patients aged five years and above. It is not intended for the relief of acute bronchospasm.
This approval marks Amneal’s first metered-dose inhaler (MDI) product and represents a key step in the company’s expansion into complex respiratory therapies. The milestone highlights Amneal’s ongoing investment in advanced inhalation development at its dedicated respiratory manufacturing facility.
The most common side effects associated with beclomethasone dipropionate HFA inhalation aerosol include headache, pharyngitis, upper respiratory tract infection, rhinitis, increased asthma symptoms and sinusitis.
According to IQVIA, U.S. annual sales of beclomethasone dipropionate HFA inhalation aerosol for the 12 months ending August 2025 were approximately $329 million.
Source: globenewswire.com
