Jubilant Life gets USFDA nod for generic anti-asthma tablets

Drug firm Jubilant Life Sciences has received final approval from the US health regulator for generic Montelukast Sodium chewable tablets used in the treatment of asthma and to relieve symptoms of seasonal allergies.
"The company has received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (USFDA) for Montelukast Sodium chewable tablets..." Jubilant Life Sciences said in a statement.
The approval is for the product in the strengths of 4 mg and 5 mg, it added.
"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.
As on December 31, 2014, the company had a total of 781 filings for formulations of which 333 have been approved in various regions globally," Jubilant Life Sciences said.
"This includes 72 ANDAs filed in the US, of which 35 have been approved and 46 dossier filings in Europe. So far, we have received 10 ANDA approvals during FY2015," it added.
Shares of Jubilant Life Sciences today closed at Rs 159.30 on BSE, down 0.22 per cent from previous close.