Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Paroxetine Extended-Release Tablets USP, 12.5 mg. This approval confirms that Alembic’s product is therapeutically equivalent to the reference listed drug product, Paxil CR Tablets, 12.5 mg, manufactured by Apotex Inc.
The Paroxetine extended-release tablets are indicated for the treatment of several disorders, including Major Depressive Disorder (MDD), Panic Disorder (PD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD). For more detailed indications, users are advised to refer to the product label.
This latest approval contributes to Alembic’s impressive tally of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals.
Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company based in India. The company is renowned for manufacturing and marketing generic pharmaceutical products globally. Alembic’s research and manufacturing facilities have received approval from regulatory authorities in several developed countries, including the USFDA. In India, Alembic is a leader in branded generics, with its products being widely recognised by healthcare professionals and patients alike.
For further information, Alembic Pharmaceuticals can be contacted through their official website or via Ajay Kumar Desai at +91 22-66953681 or [email protected].
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).