From Our 2012 Archives

Generic Singulair Approved

FDA: 10 Generic Drugmakers Approved to Make Montelukast Tablets

By Daniel J. DeNoon
WebMD Health News

Reviewed by Louise Chang, MD

Aug. 3, 2012 -- The FDA today gave 10 generic drugmakers approval to start making generic versions of Singulair (montelukast sodium), the popular asthma and allergy drug.

Singulair, usually taken in the form of tablets, has been a blockbuster drug for Merck. The company has said that it expects sales to drop by 90% as generic montelukast hits the market. Singulair sales were $1.43 billion in the last quarter before the generic announcement.

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.

Montelukast is a type of drug called a leukotriene receptor antagonist. It blocks the action of body chemicals -- leukotrienes -- that cause symptoms of asthma and hay fever.

The drug is not intended for sudden asthma attacks. And side effects can be serious. People taking montelukast should get immediate medical help if they experience:

In clinical trials, common side effects in patients taking Singulair were upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache, flu, runny nose, and sinus infection.

To get FDA approval, generic drugmakers have to make a product with the same manufacturing, packaging, and quality standards as the name-brand product.

SOURCES: News release, FDA.Associated Press, July 27, 2012.

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