Three Indian firms get US FDA nod for generic Singulair

Three Indian firms (Aurobindo Pharma, Glenmark Generics and Torrent Pharmaceuticals) have received the US FDA’s approval for the first generic versions of Merck’s Singulair (montelukast sodium). Besides these firms, global generic firms like Apotex Inc, Endo Pharmaceuticals, Kudco Ireland, Mylan, Roxane Laboratories, Sandoz, and Teva Pharmaceuticals have also got the nod.

While Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva, and Torrent have received approval for chewable tablets, Teva has received approval for the oral granule form.

Singulair was a blockbuster drug reported to have annual sales of $5 billion.

Montelukast sodium is indicated for prophylaxis and chronic treatment of asthma in adults and paediatric patients 12 months of age and older; prevention of exercise-induced broncho-constriction in patients 15 years of age and older; relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and paediatric patients two years of age and older, and perennial allergic rhinitis in adults and paediatric patients six months of age and older).

EP News Bureau

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