Ajanta Pharma gets approvals for three ANDAs

Read Article

Montelukast tablets are indicated for the 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

Ajanta Pharma has received final approval for its three ANDAs (Abbreviated New Drug Application) 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 5237 million, 587 million and 531 million respectively, according to IMS
Health. 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.

Ajanta PharmaANDAMontelukast tabletsUS FDA