Jubilant Life receives US FDA approval for asthma drug montelukast

The US Food and Drug Administration (US FDA) has granted final approval Jubilant Life Sciences Ltd’s abbreviated new drug application (ANDA) for montelukast sodium chewable tablets, 4 mg and 5 mg - a generic version of Singulair chewable tablets of Merck. According to IMS, the total market size for montelukast tablets, which is used for the treatment of asthma and to relieve symptoms of seasonal allergies, is $83 million per annum in the US.
 
As on December 31, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 333 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 35 have been approved and 46 dossier filings in Europe. Till date, it has received 10 ANDA approvals during FY 2015.