Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin Oral Suspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension, a generic version of Pfizer Inc’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. According to IQVIA, the approved product has an estimated market size of $71 million for the twelve months ending August 2018.
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 LLC and 29 tentative approvals) from USFDA.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.