Schering-Plough Files Two Drugs with the EMEA

Schering-Plough’s Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma, has been accepted for review by the EMEA. The EMEA has also validated the company’s MAA for nomegestrol acetate (2.5 mg) / 17 beta-estradiol (1.5mg), a combined oral contraceptive (COC).

Mometasone furoate/formoterol fumarate combines mometasone furoate, the active ingredient of the inhaled corticosteroid, Asmanex, with formoterol fumarate, the active ingredient of the long-acting beta2-agonist, Foradil, administered via a single metered-dose inhaler.

“These two regulatory milestones are important steps toward advancing our late-stage pipeline and meeting patient needs. If approved by the EMEA, the mometasone furoate/formoterol fumarate combination would represent an important additional treatment option for physicians and their patients and further strengthen Schering-Plough’s portfolio of respiratory products,” said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. “Schering-Plough is also committed to providing women a variety of birth control options to meet diverse lifestyle needs and choices.”

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