FDA Approves Generic Versions Of Singulair To Treat Asthma, Allergies

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8/5/2012 4:58 AM ET

The U.S. Food and Drug Administration said that on Friday it 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).

The FDA advised that Montelukast should not be used for relief of a sudden asthma attack. Some side effects of montelukast can be serious.

In clinical trials, the most common side effects reported by patients using Singulair included: upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, ear ache, flu, runny nose, and sinus infection.

The FDA noted that Apotex Inc., Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc., Mylan Inc.(MYL: Quote), Roxane Laboratories, Sandoz Inc., Teva Pharmaceuticals Inc. (TEVA: Quote), 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.

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by RTT Staff Writer

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