Schering-Plough has filed a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate in US, which is accepted for review by the FDA.
The company 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.
Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: We are pleased to announce the US filing of the fixed-dose combination of mometasone furoate and formoterol fumarate. If approved by the FDA, the mometasone fuorate/formoterol combination would represent an important additional treatment option for physicians and their patients.