August 15, 2012

FDA Approves Generic Version of Singulair;
Supply Is On the Way

Washington, D.C.—With Singulair having $4.9 billion in sales in the past year, pharmacists clearly are dispensing a lot of the asthma and allergy drugs. Recent FDA approval of the first generic versions of montelukast sodium is expected to only increase the demand.

Some pharmacies should already have the products on their shelves by now. For example, Huntsville, Alabama-based Qualitest Pharmaceuticals, owned by Endo Health Solutions Inc., already had begun shipping generic versions of tablets and chewable tablets on the Monday after the Friday approval. Indian pharmaceutical firms Aurobindo Pharma and Glenmark also said they would immediately commence distribution of their generic versions.

Montelukast is a leukotriene receptor antagonist, blocking the leukotrienes that can cause symptoms of asthma and allergic rhinitis.

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

Patients should be cautioned not to use Montelukast for relief of a sudden asthma attack, according to the FDA, which also said some side effects of the drug can be serious.

Among the side effects requiring intervention are behavior and mood-related changes such as aggression, depression, or hallucinations; a feeling of “pins and needles” or numbness in the arms or legs; rash; flu-like symptoms; and severe pain and swelling of the sinuses.

More common and usually less serious side effects include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache, flu, runny nose, and sinus infection.

FDA approved Apotex Inc., Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc., Mylan Inc., Roxane Laboratories, Sandoz Inc., Teva Pharmaceuticals Inc., and Torrent Pharmaceuticals for generic montelukast tablets. Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva, and Torrent were approved for chewable tablets. Teva was approved for the oral granule form.

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