FDA Tentatively Clears Amneal Generic Asthma Inhaler

The US Food and Drug Administration (FDA) has tentatively approved Amneal Pharmaceuticals Inc.'s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol (40 mcg/actuation and 80 mcg/actuation), according to the multinational biopharmaceutical company with its headquarters located in Bridgewater.

The product is the generic version of QVAR (beclomethasone dipropionate HFA) inhalation aerosol, which is a registered trademark of Teva Group Company IVAX LLC.

A corticosteroid called beclomethasone dipropionate HFA inhalation aerosol is prescribed as a preventative measure for asthmatic patients aged five and up. For the treatment of acute bronchospasm, it is not recommended.

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This marks a major turning point in Amneal Pharmaceuticals' progress into complex respiratory therapeutics and is the company's first metered-dose inhaler (MDI) inhalation product. It also creates a new growth vector for the inexpensive medicines category.

“Our first metered-dose inhalation product is a landmark achievement for Amneal,” said Dr. Srinivas Kone, senior vice president, 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 for pharmaceutical company  vector within our Affordable Medicines segment.”