Ajanta Pharma USA Inc, a subsidiary of Ajanta Pharma Limited, yesterday announced the launch of montelukast sodium IR tablets (10mg) and chewable tablets (4 mg & 5 mg), generic version of Merck’s Singulair that is used to prevent asthma attacks in adults and children as young as 12 months old. The US Food & Drug Administration (FDA) approval extends the breadth of the montelukast offerings from Ajanta Pharma into three dosage forms - immediate-release (IR) tablets, chewable tablets and oral granules.
Montelukast IR tablets and chewable tablets are part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. To date, the US FDA has granted Ajanta Pharma five ANDA final approvals and two ANDA tentative approvals. An additional 19 ANDAs are pending approval from the US FDA.
