New Delhi: Drug firm Unichem Laboratories said it has received final approval from the US health regulator for its Montelukast chewable tablets used for prevention and treatment of asthma.
The company has received final abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration for generic Montelukast chewable tablets in the strengths of 4 mg and 5 mg, Unichem Laboratories said in a BSE filing.
The product is a generic version of Merck Sharp & Dohme Corporation’s Singulair tablets in the same strengths, it added.
“The product will be commercialized from Unichem’s Goa Plant,” the company said.
The tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients – 12 months of age and older, it added.
They are also used in the treatment of seasonal allergic rhinitis in adults and patients – 2 years of age and older, and perennial allergic rhinitis in patients – 6 months of age and older, Unichem said.