Marksans Pharma Receives FDA Approval for Generic Benzonatate Capsules, Shares Surge 9%
Key Insights
Marksans Pharma Ltd received final FDA approval for its generic Benzonatate capsules in 100mg and 200mg strengths, bioequivalent to Pfizer's Tessalon Capsules.
The non-narcotic antitussive medication treats persistent cough (search), bronchitis (search), pneumonia (search), and other lung infections (search) by numbing respiratory tract stretch receptors (search).
Following the regulatory approval announcement, Marksans Pharma shares skyrocketed 9% initially before closing 6.01% higher at Rs 166.32 on NSE.
Marksans Pharma Ltd announced Wednesday that it has secured final approval from the US Food and Drug Administration (USFDA (search)) for its generic version of Benzonatate capsules, a non-narcotic cough suppressant used to treat persistent cough (search), bronchitis (search), pneumonia (search), and other lung infections (search). The regulatory milestone triggered a significant market response, with shares initially surging 9% before settling at a 6.01% gain.
FDA Approval Details
The USFDA (search) approval covers Marksans Pharma's abbreviated new drug application (ANDA) for Benzonatate capsules in both 100mg and 200mg strengths. According to the company's regulatory filing, the product demonstrates bioequivalence and therapeutic equivalence to Pfizer Inc's reference listed drug, Tessalon Capsules.
Benzonatate functions as a non-narcotic antitussive that numbs stretch receptors (search) in the respiratory tract, effectively reducing the cough reflex and providing relief from persistent cough (search) associated with bronchitis (search), pneumonia (search), and other lung infections (search).
Market Performance and Investor Response
The approval announcement generated immediate investor enthusiasm, with Marksans Pharma shares initially skyrocketing 9% on April 1st. By market close at 3:30 pm, the stock had settled at Rs 166.32 on the NSE, representing a solid 6.01% gain for the trading session.
Recent Regulatory Successes
This latest FDA approval builds on Marksans Pharma's recent regulatory achievements. In November of the previous year, the company's wholly-owned subsidiary received final FDA approval for over-the-counter Loperamide Hydrochloride Tablets USP, 2mg. Loperamide Hydrochloride is an anti-diarrheal medication used to treat both acute and chronic diarrhea (search) symptoms.
The consecutive approvals demonstrate Marksans Pharma's growing presence in the US generic pharmaceutical market and its ability to successfully navigate the complex FDA approval process for multiple therapeutic areas.