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Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
Date:7/22/2009

KENILWORTH, N.J., July 22 /PRNewswire-FirstCall/ -- Schering-Plough today 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 U.S. 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((R) )(mometasone furoate inhalation powder), with the long-acting beta2-agonist, FORADIL((R)) (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 U.S. filing of the fixed-dose combination of mometasone furoate and formoterol fumarate," said Thomas P. Koestler, Ph.D., 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 (1). 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.

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