The FDA recently approved the development of generic versions of leukotriene receptor antagonist Singulair, according to a press release.
Singulair (montelukast sodium, Merck) relieves asthma and allergy symptoms in adults and children. Approval for generic tablets has been issued to Apotex, Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland, Mylan Pharmaceuticals, Roxane Laboratories, Sandoz, Teva Pharmaceuticals and Torrent Pharmaceuticals. All but Glenmark received approval to develop chewable tablets, and Teva also will develop an oral granule form.
The drug is not intended for use during a sudden asthma attack. Side effects observed during Singulair clinical trials include upper respiratory and/or sinus infections, fever, sore throat, diarrhea, stomach pain and cough. Serious side effects can include changes in behavior or mood, numbness in the limbs, rash, flu-like symptoms and severe sinus pain and swelling.
“For people who suffer from chronic health conditions such as asthma and allergies, it is important to have effective and affordable treatment options,” Gregory P. Geba, MD, MPH, director of the FDA’s Office of Generic Drugs, said in the press release. “The generic products approved … will expand those options for patients.”