Glenmark Pharmaceuticals receives tentative USFDA approval for anti-asthma tablets

29 November 2011: Glenmark Pharmaceuticals has received tentative approval from the US health regulator to market its generic Montelukast Sodium tablets used for treating asthma and seasonal allergies. Glenmark Generics Inc has received tentative approval from the United States Food and Drug Administration (USFDA) for Montelukast Sodium tablets in the strength of 10 mg. The tablets are generic version of Merck's Singulair tablets, adding 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 30 September 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.

Source: Economic Times