Workflow
Tessalon Capsules
icon
Search documents
Marksans Pharma gets USFDA nod for generic Benzonatate capsules
BusinessLine· 2026-04-01 09:08
Core Viewpoint - Marksans Pharma Ltd has received final approval from the USFDA for its generic version of Benzonatate capsules, which are used to treat persistent cough, bronchitis, pneumonia, and other lung infections [1][2]. Group 1: Regulatory Approval - The approval is for the company's abbreviated new drug application (ANDA) for Benzonatate capsules in strengths of 100 mg and 200 mg [1]. - The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Tessalon Capsules, 100 mg and 200 mg, from Pfizer Inc [2]. Group 2: Product Information - Benzonatate is a non-narcotic antitussive that numbs stretch receptors in the respiratory tract, thereby reducing the cough reflex and relieving symptoms associated with persistent cough, bronchitis, pneumonia, and other lung infections [2].