Amneal Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol, the generic equivalent of QVAR®. This marks Amneal's first metered-dose inhalation (MDI) product and signals the company's expansion into complex respiratory therapies. The product is indicated for the maintenance treatment of asthma in patients five years of age and older. According to IQVIA, U.S. annual sales for the reference product reached approximately $329 million for the 12 months ending August 2025. The approval is specific to Amneal Pharmaceuticals Inc.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amneal Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9564503-en) on October 29, 2025, and is solely responsible for the information contained therein.