India, April 1 -- Marksans Pharma Ltd has received final approval from the US Food and Drug Administration for its generic version of Benzonatate capsules, used to treat persistent cough, bronchitis, pneumonia, and other lung infections.
The approval pertains to the company's abbreviated new drug application (ANDA) for Benzonatate capsules in 100 mg and 200 mg strengths, as per a regulatory filing.
Marksans Pharma said the product is bioequivalent and therapeutically equivalent to the reference listed drug, Tessalon capsules, marketed by Pfizer Inc.
Published by HT Digital Content Services with permission from Dion Global Solutions Limited....