Glenmark Pharmaceuticals has received tentative approval from the US health regulator to market its generic Montelukast Sodium tablets in the strength of 10mg which is used for treating asthma and seasonal allergies. Glenmark Generics should be able to launch the product upon patent expiry in August 2012.
The tablets are generic version of Merck's Singulair tablets and that as per IMS health data Singulair tablets in the strength of 10 mg recorded sales of USD 3.2 billion for the 12 months ended September 30,2011. The company presently has 73 products authorised for distribution in the US market and has over 40 abbreviated new drug applications (ANDAs) pending approval from USFDA.
