Unichem receives ANDA approval for Montelukast Chewable Tablets

04 Jul 2018 Evaluate

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.

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