FDA approves generic Singulair
  • Mon, 08/06/2012 - 3:06pm

The U.S. Food and Drug Administration recently approved 10 drug makers’ generic versions of Merck’s Singulair (montelukast sodium), an oral asthma medication used in the long-term management of asthma symptoms.

The FDA allowed the following companies to market montelukast sodium tablets: Apotex, Aurobindo Pharma, Endo, Glenmark Generics, Kudco Ireland, Mylan, Roxane Laboratories, Sandoz, Teva and Torrent. The FDA also approved Glenmark’s chewable montelukast sodium tablets and Teva’s granule tablets.

Other asthma medications work to stop the release of histamine, which MedicineNet defines as a naturally occurring substance that the body releases during allergic reactions. Montelukast sodium stops the actions of chemicals in the body called leukotrienes, which WebMD says produce the inflammation that causes asthma.

MedicineNet defines asthma as a common, chronic condition in which the lungs’ airways swell and contract, making it hard for a person to breathe. The condition affects one in every 15 children and five percent of adults in North America, the site says.

In its announcement, the FDA stressed that montelukast sodium should not be taken to treat severe asthma attacks or allergic reactions. It also reported common side effects, including:

  • upper respiratory infection
  • fever
  • headache
  • sore throat
  • cough
  • stomach pain
  • diarrhea
  • earache
  • flu
  • runny nose
  • sinus infection

The FDA also noted that the drug can occasionally have serious side effects, such as:

  • feeling “pins and needles” or numbness in the arms or legs
  • changes in mood or behavior, including aggression, depression or hallucinations
  • rash
  • symptoms similar to the flu
  • acute pain  and swelling of the sinuses

If you experience any of these adverse effects while taking montelukast sodium, please contact your physician immediately.



About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

Related Posts