Aurobindo Pharma receives US FDA approval for Azithromycin oral suspension

The product will be launched in November 2018

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Azithromycin oral suspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension, a generic version of Pfizer’s Zithromax oral suspension. The product will be launched in November 2018.

Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections. The approved product has an estimated market size of $ 71 million for the twelve months ending August 2018, according to IQVIA. This is the 125th ANDA (including 11 tentative approvals) to be approved out of Unit III formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 386 ANDA approvals (357 Final approvals including 19 from Aurolife Pharma and 29 tentative approvals) from US FDA