Ajanta Pharma receives US FDA nod for 3 ANDAs

Ajanta Pharma has received the final approval from US Food and Drug Administration (US FDA) for its three ANDAs (abbrevaited new drug applications) for montelukast tablets, sodium chewable tablets and oral granules.
 
Montelukast sodium chewable tablets, 10 mg, the generic version of singulair tablets by Merck, is indicated for treatment of prophylaxis and chromic treatment of asthma and to relieve symptoms of seasonal and perennial allergic rhinitis in patients two years of age and older.

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For the 12 months ending June 2015, montelukast tablets, chewable tablets and oral granules had sales of approximately $237 million, $87 million and $31 million respectively, according to IMS Health.