Written on: November 4, 2025 by SprayTM
Amneal Pharmaceuticals, Inc. announced that the U.S. Food & Drug Administration (FDA) has tentatively approved the company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol. The product is the generic equivalent of QVAR, a registered trademark of IVAX LLC, a member of the Teva Group.
Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients five years of age and older, said the company. It is not indicated for the relief of acute bronchospasm.
This represents Amneal’s first metered-dose inhaler (MDI) inhalation product.
“Our first metered-dose inhalation product is a landmark achievement for Amneal,” said Srinivas Kone, Senior VP & 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.”
