Aurobindo Pharma receive US FDA approval for manufacture and market entacapone tablets and azithromycin for injection
Aurobindo Pharma got final approvals from the US FDA of azithromycin for injection USP, 500mg /vial and entacapone tablets. 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, 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.
The approved ANDA for entacapone tablets is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Comtan tablets 200mg of Orion Corporation. Entacapone tablets are used in the treatment of Parkinson's disease.
Aurobindo now has 12 ANDAs (represented by 9 product classes) approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC.