FDA Approves Generic Versions of Singulair

The FDA has approved generic versions of Merck's Singulair (montelukast sodium) to control asthma symptoms and to relieve the symptoms of indoor and outdoor allergies in both adults and children.

Generic tablet and chewable tablet formulations have been approved for Apotex, Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics (tablets only), Kudco Ireland, Mylan, Roxane Laboratories, Sandoz, Teva, and Torrent. Teva has also received approval for the oral granule form.Qualitest (part of Endo Pharmaceuticals) has launched and begun shipping Montelukast tablets and chewable tablets.

Montelukast, a leukotriene receptor antagonist, is indicated for seasonal allergic rhinitis (for patients >2 years old), perennial allergic rhinitis (for patients >6 months old), prophylaxis and chronic treatment of asthma (for patients ≥12 months old), and prevention of exercise-induced bronchoconstriction (for patients ≥15yrs old).

For more information call (888) INFO-FDA or visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314436.htm.