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Ajanta Pharma gets approvals for three Abbreviated New Drug Applications

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Ajanta Pharma has received final approval for its three Abbreviated New Drug Application (ANDAs) by US FDA for Montelukast tablets, 10 mg, Montelukast sodium chewable tablets, 4mg and 5mg and Montelukast oral granules.

Montelukast sodium tablets, 10 mg, the generic version of Singulair tablets by Merck, is indicated for treatment of prophylaxis and chronic treatment of asthma and to relieve symptoms of seasonal and perennial allergic rhinitis in patients two years of age and older.

Montelukast 4mg chewable tablets are suitable for two to five year-old patients while Montelukast 5mg chewable tablets are available for patients from six to 14 years of age. Montelukast oral granules are specially appropriate for patients of 12 months of age and older.

For the 12 months ending June 2015, Montelukast tablets, chewable tablets and granules had sales of approximately $237 million, $87 million and $31 million respectively, according to IMSHealth. Ajanta intends to launch these products shortly.

The approval of the Montelukast product family is part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. Including these three ANDA approvals, Ajanta now has five approved ANDAs and another 20 ANDAs under approval with FDA.

EP News BureauMumbai

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