Schering-Plough, Merck Say Allergy-Drug Filing Accepted
Schering-Plough and Merck Tuesday said U.S. regulators had accepted the marketing application for their experimental allergy drug, which combines two widely used existing treatments into a single tablet.
A joint venture between the two drugmakers is developing the product, which includes the active ingredients of Schering-Plough's Claritin allergy medicine and Merck's Singulair treatment for allergy and asthma.
The partners said the combination product would receive a standard review by the U.S. Food and Drug Administration -- which typically means the agency will respond within 10 months.
The active ingredient of Claritin, loratadine, is an antihistamine sold by a number of companies in over-the-counter forms.
The active ingredient of Singulair, a $4 billion-a-year drug available by prescription, is called montelukast. It works by controlling proteins called leukotrienes, which also trigger allergic symptoms such as stuffy nose and sneezing.
The Schering-Plough/Merck joint venture successfully developed and now sells Zetia and Vytorin, two popular cholesterol fighters that have been linchpins of growing profitability for the two drugmakers.