Schering-Plough Receives Acceptance From EMEA For Two European Filings

Published: 26-Aug-2009

Nomegestrol acetate/17 beta-estradiol, an oral treatment for women to prevent pregnancy

Schering-Plough has announced that EMEA has accepted its Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate, for the maintenance treatment of asthma in patients 12 years of age and older.

Reportedly, EMEA has validated the MAA for nomegestrol acetate (2.5mg)/17 beta-estradiol (1.5mg), a combined oral contraceptive (COC) containing a combination of a natural estrogen identical to the estrogen produced by a woman's own body and a selective progestin, for review

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.

Thomas Koestler, president and executive vice president of Schering-Plough Research Institute, said: 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. 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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