Aurobindo Pharma, Glenmark get FDA nod for generic montelukast sodium tablets

New Delhi Drug firms Aurobindo Pharma and Glenmark have received approval from the US health regulator to manufacture and market generic montelukast sodium tablets used for treating asthma and allergies. They would immediately commence distribution of the product.

The annual sales of montelukast sodium tablets 10 mg were nearly $3.5 billion and that of chewable tablets were $1.1 billion in 2011-12. The tablets are generic version of pharma major Merck & Co's Singulair tablets, indicated for the treatment of asthma, allergic rhinitis and prophylaxis.

Last week, the USFDA had approved sales of generic version of Singulair by various firms, including Indian companies Aurobindo Pharma, Glenmark Generics and Torrent Pharmaceuticals.