Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Montelukast Sodium tablets 10mg (ANDA 202468) and Montelukast Sodium Chewable tablets 4mg and 5mg (ANDA 202096). The products are ready for a first-day launch.
Montelukast Sodium tablets 10mg and Chewable tablets 4mg and 5mg are the generic equivalent of Merck & Company Inc’s Singulair tablets 10mg and Chewable tablets 4mg and 5mg respectively. Montelukast Sodium is indicated for Prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
According to IMS, the annual sales of Montelukast Sodium tablets 10mg is approximately $3.5 billion and that of Montelukast Sodium Chewable tablets is $1.1 billion for the twelve months ending March 2012.
The products have been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India. The company now has a total of 157 ANDA approvals (131 final approvals including 1 from Aurolife Pharma LLC and 26 tentative approvals from USFDA.
Aurobindo Pharma has a product presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. The company is the market leader in semi-synthetic penicillin drugs.
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