Unichem Laboratories Limited has received ANDA approval from the US Food and Drug Administration (FDA) for asthma drug, montelukast sodium tablet.
Montelukast sodium tablets 10 mg are therapeutically equivalent to Singulair tablets 10 mg of Merck Sharp & Dohme Corp.
Montelukast is a leukotriene receptor antagonist (LTRA) which is indicated for prophylaxis and chronic treatment of asthma in adults and adolescents patients. It is also used to prevent exercise-induced bronchoconstruction and to provide relief from symptoms of allergic rhinities in adults and adolescents patients.
The product will be commercialised from Unichem's Goa plant.
The company now has total of 19 ANDA approvals (including 3 tentative approvals) from US FDA.
