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US FDA approves generic versions of Merck’s Singulair

(Reuters) – The U.S. Food and Drug Administration on Friday said it granted 10 drugmakers marketing approvals for the first generic forms of Singulair (montelukast sodium), the $5 billion-a-year asthma and allergy drug that is Merck & Co Inc’s best-selling product.

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.

The FDA said information about the availability of generic montelukast sodium can be obtained from the manufacturers.

Singulair, unlike most allergy drugs which block the protein histamine, instead blocks proteins leukotrienes, which cause inflammation.

“For people who suffer from chronic health conditions such as asthma and allergies, it is important to have effective and affordable treatment options,” said Dr. Gregory P. Geba, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, in a statement. “The generic products approved today will expand those options for patients.”