Amneal Pharmaceuticals Announces FDA's Approval For Albuterol Sulfate Inhalation Aerosol

Benzinga · 4d ago

Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC.

This approval follows the Company's FDA approval of its beclomethasone dipropionate inhalation aerosol, a generic equivalent of QVAR® (beclomethasone dipropionate inhalation aerosol), further advancing Amneal's entry into complex inhaled and respiratory drug delivery. Together, these milestones underscore the Company's momentum in building a differentiated, high-value respiratory portfolio supported by its state-of-the-art manufacturing platform.