Amneal Pharmaceuticals Inc., a global biopharmaceutical company headquartered in Bridgewater, has announced that the USA 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/actuation and 80 mcg/actuation strengths.

The product is the generic equivalent 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 indicated for the maintenance treatment of asthma as a prophylactic therapy in patients aged five years and older. It is not indicated for the relief of acute bronchospasm.

This approval marks a significant milestone for Amneal, representing the company’s first metered-dose inhaler (MDI) product and establishing a new growth vector within its Affordable Medicines segment. It also reinforces Amneal’s expansion into complex respiratory therapies.

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

The most common adverse reactions associated with beclomethasone dipropionate HFA inhalation aerosol include headache, pharyngitis, upper respiratory tract infection, rhinitis, increased asthma symptoms, and sinusitis.

According to IQVIA, USA annual sales for beclomethasone dipropionate HFA inhalation aerosol for the 12 months ending August 2025 were approximately USD 329 million.

Amneal Pharmaceuticals develops, manufactures, and distributes a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. The company’s Affordable Medicines segment focuses on expanding across complex product categories such as injectables, inhalation therapies, and biosimilars. Its Specialty segment features branded pharmaceuticals targeting central nervous system and endocrine disorders, while its AvKARE division supplies pharmaceuticals and related products to USA federal, retail, and institutional markets.