Marksans Pharma Wins USFDA Approval for Benzonatate Generic

Marksans Pharma Ltd has secured USFDA approval for its generic Benzonatate capsules, which treat persistent cough and lung infections. The capsules are bioequivalent to Pfizer's Tessalon Capsules. This approval marks a step forward for Marksans in the US pharmaceutical market.

Marksans Pharma Ltd announced Wednesday that it has received final approval from the United States Food and Drug Administration (USFDA) for its generic version of Benzonatate capsules. These capsules are indicated for the treatment of persistent cough, bronchitis, pneumonia, and other lung infections.

The approval pertains to the company's abbreviated new drug application (ANDA) for Benzonatate capsules in strengths of 100 mg and 200 mg. Marksans Pharma noted in a regulatory filing that their product is bioequivalent and therapeutically equivalent to the reference listed drug, Tessalon Capsules, produced by Pfizer Inc.

Benzonatate is classified as a non-narcotic antitussive, working by numbing stretch receptors in the respiratory tract. This action reduces the cough reflex, offering relief from persistent cough and various lung infections. The approval is a significant milestone for Marksans Pharma's presence in the US market.

(With inputs from agencies.)