Aurobindo Pharma receives approval for Azithromycin for injection and Entacapone tabs

Azithromycin for injection is indicated for treatment of patients with community-acquired pneumonia and pelvic inflammatory disease

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market Azithromycin for Injection USP, 500mg /vial (ANDA 203294). The company has also received approval to manufacture and market Entacapone tablets USP, 200mg (ANDA 203437). The product will be launched soon.

Azithromycin for injection USP, 500mg /vial is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zithromax (Azithromycin for injection) 500mg/vial of Pfizer. Azithromycin for injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions such as community-acquired pneumonia and pelvic inflammatory disease.

Entacapone tablets are used in the treatment of Parkinson’s disease and has an estimated market size of $59 million for the twelve months ending April 2015 according to IMS.