FDA Approves Generic Singulair

Disclosures

August 03, 2012

August 3, 2012 — The US Food and Drug Administration (FDA) today approved the first generic versions of the asthma and allergy drug montelukast sodium (Singulair, Merck), which will be marketed by 10 different pharmaceutical companies.

In 2010, Singulair racked up $4.1 billion in sales, good for seventh place on the list of the 10 best-selling drugs, according to IMS, a pharmaceutical market intelligence firm.

The companies approved to market generic montelukast tablets are:

  • Apotex

  • Aurobindo Pharma

  • Endo Pharmaceuticals

  • Glenmark Generics

  • Kudco Ireland

  • Mylan

  • Roxane Laboratories

  • Sandoz

  • Teva Pharmaceuticals

  • Torrent Pharmaceuticals

All the companies except Glenmark Generics also received approval to market a chewable montelukast tablet. Teva was cleared for an oral granule form of the drug.

Montelukast is indicated for children and adults to control asthma symptoms and relieve symptoms of indoor and outdoor allergies. Patients should not use it to relieve a sudden asthma attack.

The most common adverse events reported by patients taking montelukast in clinical trials were upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache, influenza, runny nose, and sinus infection.

More serious adverse events are behavior and mood-related changes such as aggression, depression, or hallucinations; numbness in legs and arms; rash; influenza-like symptoms; or severe pain and swelling of the sinuses. Patients experiencing these symptoms should contact their healthcare provider immediately, according to the FDA.

More information on the FDA announcement is available on the agency's Web site.

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