Zenara Pharma receives US FDA approval for generic Sertraline Hydrochloride Capsules

 Zenara Pharma, a Biophore company, has announced that it has received final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Capsules in 150 mg and 200 mg strengths. 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 the CGT pathway, Zenara’s ANDA qualifies for 180 days of marketing exclusivity in the United States. The exclusivity period began with the product’s commercial launch.

Sertraline Hydrochloride Capsules belong to the class of selective serotonin reuptake inhibitors (SSRIs). The medication is indicated for the treatment of Major Depressive Disorder (MDD) in adults, as well as Obsessive-Compulsive Disorder (OCD) in adults and in paediatric patients aged six years and older.

Dr. Srinivas Arutla, Chief Executive Officer of Zenara Pharma, said, “Receiving the first generic approval for Sertraline Hydrochloride Capsules highlights Zenara’s strong R&D capabilities and operational excellence. We remain committed to our mission of delivering to patients, early access to high-quality, affordable pharmaceuticals.”

According to IQVIA sales data for the 12-month period ending June 2025, sales of the reference listed product in the United States totalled approximately $35.5 million.