Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) announced the U.S. launch of beclomethasone dipropionate HFA inhalation aerosol. This is one of the Company’s first two metered-dose inhalation (MDI) product launches in the U.S., marking Amneal’s entry into the complex inhalation category.
Beclomethasone dipropionate HFA inhalation aerosol (40 mcg and 80 mcg per actuation) is the first and only generic equivalent of the original QVAR® Inhalation Aerosol, 40 mcg and 80 mcg. It utilizes the hand-breath actuator device in which the cannister is depressed by the patient before inhaling. This option was previously discontinued for QVAR®, creating a potential gap in patient choice.
“Manufactured at our dedicated inhalation facility in Ireland, these complex products reflect our ability to develop and scale difficult-to-make formulations that address meaningful gaps in patient access,” said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines.
Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. It is not indicated for the relief of acute bronchospasm.
The most common adverse reactions reported with the use of beclomethasone dipropionate HFA inhalation aerosol include headache, pharyngitis, upper respiratory tract infection, rhinitis, increased asthma symptoms, and sinusitis. See full prescribing information for more information.
