Montelukast Sodium chewable tablets used in the treatment of asthma and to relieve symptoms of seasonal allergies developed by Jubilant Life Sciences received final approval for the generic from the US health regulator.
Jubilant Life Sciences said in a statement, "The company has received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (USFDA) for Montelukast Sodium chewable tablets of 4 mg and 5 mg."
The company had a total of 781 filings for formulations of which 333 have been approved in various regions globally and includes 72 ANDAs filed in the US, of which 35 have been approved and 46 dossier filings in Europe. So far, it has received 10 ANDA approvals during FY2015.
"The total market size for Montelukast tablets as per IMS is USD 83 million per annum," Jubilant Life Sciences said.
The tablets are generic version of Merck's Singulair chewable tablets used for the treatment of asthma and to relieve symptoms of seasonal allergies, it added.