India-based Zenara Pharma Private Limited, a Biophore company, announced on Thursday that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) 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.

The product has also been granted Competitive Generic Therapy (CGT) designation by the FDA. As the first approved applicant under this pathway, Zenara's ANDA has secured 180 days of marketing exclusivity in the United States, which commenced with the product's launch.

Sertraline Hydrochloride Capsules are classified as selective serotonin reuptake inhibitors (SSRIs) and are indicated for the treatment of Major Depressive Disorder (MDD) in adults and obsessive-compulsive disorder (OCD) in adults and paediatric patients aged six years and older.