Morningstar

Amneal Gets Tentative FDA Approval for Asthma Treatment

Provided by Dow Jones Oct 29, 2025, 9:45:00 PM

By Kelly Cloonan

Amneal has received tentative approval from the Food and Drug Administration for an inhalation aerosol to treat asthma.

The biopharmaceutical company said the product, called beclomethasone dipropionate HFA inhalation aerosol, is the generic equivalent of Qvar, an inhalation aerosol sold by Teva Group.

The product is indicated for the maintenance treatment of asthma in patients five years of age and older, the company said.

It is Amneal's first metered-dose inhaler inhalation product, marking progress in the company's expansion into complex respiratory therapies.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

October 29, 2025 17:45 ET (21:45 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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