US Food and Drug Administration (FDA) has approved Ajanta Pharma to market its generic montelukast tablets and oral granules. It is used for the prevention and treatment of asthma and also to relieve symptoms of seasonal hay fever.
"The company has received final approval for its three abbreviated new drug applications (ANDAs) by the United States Food and Drug Administration (USFDA) for montelukast tablets, montelukast sodium chewable tablets and montelukast granules", said Ajanta Pharma.
While the approval is for montelukast tablets in the strength of 10 mg, montelukast sodium chewable tablets have received nod for strengths of 4mg and 5 mg. The company plans to launch the generic products shortly, it added.
Montelukast 4mg chewable tablets are for 2 to 5 year old patients, 5mg tablets are for patients from 6 to 14 years of age and Montelukast oral granules are specially appropriate for patients of 12 months of age and older.
"For 12 months ending June 2015, montelukast tablets, chewable tablets and granules had sales of approximately $237 million, $87 million and $31 million respectively," said Ajanta Pharma.
Ajanta Pharma is among the fastest growing pharmaceutical companies in the indian market. Its main focus is on fast growing therapeutic segments of Cardiology, Ophthalmology, Dermatology and Pain Management.