Glenmark gets tentative US FDA nod for asthma drug

Moneycontrol Bureau

Glenmark Generics Inc USA has received tentative approval from US Food and Drugs Administration for Montelukast Sodium 10 mg tablets, a generic version of pharma major Merck's Singulair tablets. Singulair tablets are indicated for prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, among other ailments. "Based on the tentative approval for Montelukast Sodium Tablets, Glenmark Generics should be able to launch the product upon patent expiry in August 2012," Glenmark Pharmaceuticals said on Monday. Singular tablets had sales of USD 3.2 billion for the year ended September 2011, Glenmark said citing IMS Health data. Glenmark said it currently has 73 products authorized for distribution in the US and has over 40 ANDAs [abbreviated new drug applications] pending approval with the US FDA. Glenmark Pharma shares were trading down 1.9% at Rs 311.40 on NSE in afternoon trade on Monday.