The U.S. Food and Drug Administration approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
Montelukast is in a class of medications called leukotriene receptor antagonists. It works by blocking the action of leukotrienes, substances in the body that cause the symptoms of asthma and hayfever (allergic rhinitis).
Apotex Inc., Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc., Mylan Inc., Roxane Laboratories, Sandoz Inc., Teva Pharmaceuticals Inc., and Torrent Pharmaceuticals have gained FDA approval for generic montelukast tablets. Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva, and Torrent have received approval for chewable tablets. Teva has received approval for the oral granule form.
Date: August 7, 2012
Source: U.S. Food and Drug Administration
Filed Under: Drug Discovery