Glenmark gets FDA tentative nod for anti-asthma tablets
Glenmark Pharmaceuticals today said it 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, Glenmark Pharmaceuticals said in a filing to BSE.
"Glenmark Generics should be able to launch the product upon patent expiry in August 2012," it added.
The tablets are generic version of Merck's Singulair tablets, Glenmark said, adding that as per IMS health data Singulair tablets in the strength of 10 mg recorded sales of $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, Glenmark said.
Shares of Glenmark Pharmaceuticals were today trading at Rs 312.05 in the afternoon trade on BSE, down 1.51% from its previous close.