Aurobindo Pharma Limited has received final US FDA approvals to manufacture and market montelukast sodium tablets 10mg and montelukast sodium chewable tablets 4mg and 5mg The products are ready for a first-day launch.
Montelukast sodium tablets 10mg and chewable tablets 4mg and 5mg are the generic equivalent of Merck & Co. Inc’s Singulair tablets 10mg and chewable tablets 4mg and 5mg respectively.
Montelukast sodium is indicated for prophylaxis and chronic treatment of asthma in adults and paediatric patients 12 months of age and older. It prevent exercise-induced broncho-constriction in patients 15 years of age and older Further, the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and paediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and paediatric patients 6 months of age and older).
The annual sales of montelukast sodium tablets 10mg is approximately US$ 3.5 billion and that of montelukast sodium chewable tablets is US$ 1.1 billion for the twelve months ending March 2012 according to IMS.
The products have been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India. Aurobindo now has a total of 157 ANDA approvals (131 Final approvals including 1 from Aurolife Pharma LLC and 26 Tentative approvals) from US FDA.
The company is marketing these products globally, in over 125 countries.