India Pharma Outlook Team | Friday, 26 September 2025
Alembic Pharmaceuticals Limited has announced today that it has obtained final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) pertaining to Paroxetine Extended-Release Tablets USP (25 mg and 37.5 mg).
This is a significant event for Alembic since this enables the company to market its generic version of the drug in the United States, one of the largest and most competitive pharmaceutical markets in the world.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Paxil CR Extended-Release Tablets, (25 mg and 37.5 mg) developed by Apotex Inc.
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Alembic expands its footprint among the US generics by introducing additional products in the central nervous system (CNS) area, one of the important therapeutic areas. Paroxetine Extended-Release Tablets are indicated for the treatment of Major Depressive Disorder (MDD), Panic Disorder (PD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD), which represents a significant area of unmet medical need.
Alembic anticipates that availability of the paroxetine generic would provide the patient's access to a lower cost treatment option while maintaining the same safety and efficacy associated with the branded product.
Following this most recent approval, Alembic has now received a total of 226 ANDA approvals, which includes 205 final approvals and 21 tentative approvals, from the USFDA. This achievement demonstrates the company's strong research and development capabilities, continuous compliance with regulations and a strong focus on developing a pipeline of complex generics for the US market.
