BioCentury
ARTICLE | Clinical News

Singulair montelukast regulatory update

August 13, 2012 7:00 AM UTC

FDA approved ANDAs for generic versions of Merck's Singulair montelukast to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Merck markets Singulair to treat asthma and allergic rhinitis, and to prevent exercise-induced bronchoconstriction. The pharma recorded 2Q12 Singulair sales of $1.4 billion and 2011 sales of $5.5 billion, including $3.5 billion in the U.S. Merck's pediatric exclusivity for oral formulations of montelukast, a leukotriene receptor antagonist, expired on Aug. 3. ...