Marksans Pharma Limited has received final approval from the USFDA for its Benzonatate Capsules (100 mg & 200 mg). This generic formulation is bioequivalent to Pfizer’s Tessalon Capsules. Used as a non-narcotic antitussive, the medication helps relieve persistent coughs associated with respiratory conditions like bronchitis and pneumonia. This approval marks another milestone in the company’s expanding global product portfolio, strengthening its presence in the competitive generic pharmaceutical market.
Expanding Generic Product Portfolio
Marksans Pharma Limited has officially secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules in both 100 mg and 200 mg strengths. This regulatory green light allows the company to market this generic prescription drug in the United States, further diversifying its therapeutic offerings.
Strategic Market Positioning
The newly approved product is confirmed to be both bioequivalent and therapeutically equivalent to the reference listed drug, Tessalon Capsules, manufactured by Pfizer Inc. By providing a generic alternative, Marksans Pharma aims to increase accessibility to effective treatment for respiratory ailments.
Understanding Benzonatate
Benzonatate is a non-narcotic antitussive medication designed to numb the stretch receptors located in the respiratory tract. This mechanism effectively reduces the cough reflex, providing relief to patients suffering from persistent coughs, bronchitis, pneumonia, and various other lung-related infections. This addition complements the company’s existing expertise in the upper respiratory therapeutic segment, where they continue to drive growth across global markets.
Source: BSE
