Schering-Plough announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate has been filed in the United States and accepted for review by the US Food and Drug Administration (FDA). Schering-Plough is seeking marketing approval from the FDA of the mometasone furoate/formoterol fumarate combination for the maintenance treatment of asthma in patients 12 years of age and older.
Mometasone furoate/formoterol fumarate combines the active ingredients of an inhaled corticosteroid, Asmanex (mometasone furoate inhalation powder), with the long-acting beta2-agonist, Foradil (formoterol fumarate inhalation powder), administered via a single metered-dose inhaler. Schering-Plough has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol furmarate fixed-dose combination.
"We are pleased to announce the US filing of the fixed-dose combination of mometasone furoate and formoterol fumarate," said Thomas P Koestler, executive vice president and president, Schering-Plough Research Institute. "If approved by the FDA, the mometasone fuorate/formoterol combination would represent an important additional treatment option for physicians and their patients and further strengthen Schering-Plough's portfolio of respiratory products."
Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and chronic obstructive pulmonary disease (COPD) medications, in terms of dollar sales. The fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma in patients younger than 12 years of age and for use in COPD is currently in phase-III development.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world.
Asmanex Twisthaler (mometasone furoate inhalation powder) is for the maintenance treatment of asthma in patients 4 years of age and older.
Foradil Aerolizer is for the maintenance treatment of asthma in those five years and older when taken on a long-term, twice-daily basis.