Jul 4: Mumbai-headquartered Unichem Laboratories Ltd has received final ANDA approval for its Montelukast Chewable Tablets, 4 mg and 5 mg from the United States Food and Drug Administration (USFDA).
“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,” the company said.
According to the company, the product is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients in 12 months of age and older, for the prevention of exercise-induced broncho constriction in patients 15 years of age and older, and also for the relief of symptoms of allergic rhinitis.
The product will be commercialized from Unichem’s Goa plant, it added.
Shares of the company were trading at Rs 242.25, up 2.54% from the previous closing of Rs 236.25, on BSE at 2.29 pm today.