FDA approves Schering-Plough’s Asmanex

KENILWORTH, N.J. The Food and Drug Administration has approved Schering-Plough’s asthma inhaler Asmanex twisthaler 110 mcg for the maintenance of asthma as a preventive therapy in patients 4 to 11 years old.

Asmanex is an inhaled corticosteroid. Asmanex 220 mcg was approved on March 31, 2005, by the FDA for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.

"As the first inhaled corticosteroid that is approved for once-daily dosing in children as young as age 4, the approval of the pediatric indication for Asmanex provides an important treatment option for children with moderate and mild persistent asthma," said Robert Spiegel, chief medical officer and senior vice president of Schering-Plough Research Institute.