July 23, 2009
FDA accepts NDA for mometasone furoate/formoterol fumarate combination for maintenance treatment of asthmaSchering-Plough announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate has been filed and accepted for review by the FDA for the maintenance treatment of asthma in patients ≥12 years of age. This fixed-dose therapy combines the active ingredients of an inhaled corticosteroid, Asmanex (mometasone furoate), with a long-acting beta2-agonist, Foradil (formoterol fumarate inhalation powder), administered via a single metered-dose inhaler.
Asmanex Twisthaler is indicated for the maintenance treatment of asthma in patients ≥4 years of age. Foradil Aerolizer is indicated for the maintenance treatment of asthma in those ≥5 years when taken on a long-term, twice-daily basis.
For more information call (800) 842-4090 or visit www.schering-plough.com.