Unichem Laboratories has received final Abbreviated New Drug Application (ANDA) approval from United States Food and Drug Administration (USFDA) for Unichem’s Montelukast Chewable Tablets 4 mg and 5 mg. Unichem’s Montelukast Chewable Tablets, 4 mg and 5 mg are the AB rated generic equivalent of Merck Sharp & Dohme Corporation’s Singulair Tablets, 4 mg and 5 mg.
This drug is indicated for prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, prevention of exercise-induced broncho constriction in patients 15 years of age and older and the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older). The Product will be commercialized from Unichem’s Goa Plant.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.
