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Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity
- Zenara Pharma Private Limited received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Sertraline Hydrochloride Capsules, 150 mg and 200 mg.
- This approval marks the first FDA-approved generic equivalent of the reference listed drug marketed by Almatica Pharma, LLC.
- Zenara's ANDA has secured 180 days of marketing exclusivity in the U.S., which commenced with the product's launch.
- Sertraline Hydrochloride Capsules are indicated for the treatment of Major Depressive Disorder and Obsessive-Compulsive Disorder in adults and pediatric patients aged six years and older.
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Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity
HYDERABAD, India, July 31, 2025 /PRNewswire/ -- Zenara Pharma Private Limited ("Zenara"), a Biophore company, today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sertraline…
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Leaning Left7Leaning Right5Center43Last UpdatedBias Distribution78% Center
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