Hyderabad-based Aurobindo Pharma has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sertraline Hydrochloride Oral Concentrate 20 mg (base)/ml. This is an ANDA filed with Paragraph IV certification.
Sertraline Hydrochloride Oral Concentrate is the generic equivalent of Pfizer’s Zoloft Oral Concentrate, which is indicated for the treatment of major depressive disorder in adults. This is Aurobindo Pharma’s 82nd ANDA approval from USFDA.