Marksans Pharma Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Benzonatate capsules indicated for treatment of persistent cough, bronchitis, pneumonia or other lung infections.
The approval by the US Food and Drug Administration (USFDA) is for the company’s abbreviated new drug application (ANDA) for Benzonatate capsules of strengths 100 mg and 200 mg, Marksans Pharma said in a regulatory filing.
This product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Tessalon Capsules, 100 mg and 200 mg, of Pfizer Inc, it added.
Benzonatate is a non-narcotic antitussive that numbs stretch receptors in the respiratory tract, reducing the cough reflex and relieving persistent cough, bronchitis, pneumonia or other lung infections, the company said.
