FDA Greenlights Asthma Drug Generics

Generic forms of the popular asthma drug montelukast sodium (Singulair) produced by 10 manufacturers have won FDA approval, the agency announced.

Montelukast is a leukotriene receptor antagonist and, unlike other most other products intended for long-term control of asthma symptoms, is available in oral form.

The 10 companies approved to sell the drug in tablet form are Apotex, Aurobindo Pharma, Endo, Glenmark Generics, Kudco Ireland, Mylan, Roxane Laboratories, Sandoz, Teva, and Torrent. All but Glenmark also were approved to sell it in chewable tablets. Additionally, Teva will be allowed to market an oral granule form.

The FDA emphasized that montelukast should not be used to relieve acute asthma attacks. It also noted that the drug can have significant adverse effects, including behavior and mood-related changes such as aggression, depression, or hallucinations; feelings of “pins and needles” or numbness in the arms or legs; rash; flu-like symptoms; and severe pain and swelling of the sinuses.

These are relatively uncommon, though. The most frequent side effects seen in clinical trials were upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, ear ache, flu, runny nose, and sinus infection, the FDA said.

Availability of the newly approved generics may vary among manufacturers. The FDA said it did not have information on when these products would be in pharmacies

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