FDA approves generic versions of asthma, allergy drug
SILVER SPRING, Md. — The Food and Drug Administration has approved several generic versions of a drug used to treat asthma and allergies, the agency said Friday.
The FDA announced the approval of montelukast sodium, a drug indicated for controlling asthma symptoms and relieving indoor and outdoor allergies.
The drug is a generic version of Merck's Singulair, which had sales of $4.6 billion in 2011, according to IMS Health.
The FDA said it approved versions of the tablet and chewable tablet formulations of the drug made by Apotex, Aurobindo Pharma, Endo Pharmaceuticals, Dr. Reddy's Labs, Kudco Ireland, Mylan, Roxane Labs, Sandoz, Teva Pharmaceuticals and Torrent Pharmaceuticals. Teva also received approval for the oral granule formulation.