Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (US FDA) for its supplemental Abbreviated New Drug Application (sANDA) for paroxetine extended-release tablets USP, 12.5 mg.

The approved product is therapeutically equivalent to the Reference Listed Drug (RLD), Paxil CR tablets, 12.5 mg, marketed by Apotex. Paroxetine extended-release tablets are prescribed for the treatment of Major Depressive Disorder (MDD), Panic Disorder (PD), Social Anxiety Disorder (SAD) and Premenstrual Dysphoric Disorder (PMDD).

With this approval, Alembic continues to strengthen its presence in the US generics market. The company now holds a cumulative total of 235 ANDA approvals from the US FDA, including 216 final approvals and 19 tentative approvals.

Established in 1907, Alembic Pharmaceuticals is a vertically integrated research and development-driven company headquartered in India. It manufactures and markets generic pharmaceutical products globally, supported by advanced research and manufacturing facilities that are approved by regulatory authorities in several developed markets, including the US.