Aurobindo Pharma receives US FDA approval for entacapone and azithromycin

Aurobindo Pharma Limited has received US drug regulator’s approval for marketing two drugs - entacapone tablet and azithromycin for injection. Food & Drug Administration (USFDA)
 
The US Food & Drug Administration (US FDA) gave its final approvals to Aurobindo Pharma for manufacturing and marketing entacapone tablet USP, 200 mg. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Comtan tablet 200 mg of Orion Corporation. Entacapone tablet, which is used in the treatment of Parkinson's disease, has an estimated market size of $ 59 million for the twelve months ending April 2015, according to IMS.
 
Similarly, the company has received final approvals from US FDA to manufacture and market azithromycin for injection USP (500mg /vial) – a bioequivalent and therapeutically equivalent to the reference listed drug product Zithromax 500mg/vial of Pfizer Inc. 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.