One of India’s leading drug-maker, Aurobindo Pharma has obtained the final approval from the US health regulator for its Azithromycin oral suspension used for the treatment of infections. According to the reports, the product is a generic version of Pfizer Inc’s Zithromax oral suspension.
Aurobindo Pharma said in a statement that the company has received the final nod from the US Food and Drug Administration (USFDA) to manufacture and market Azithromycin oral suspension 100 mg /5 mL and 200 mg/5 mL.
Aurobindo Pharma declared that the product will be launched in November 2018. According to the company’s statement, Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections.
As per IQVIA, the approved product has an estimated market size of US$ 71 million for the 12 months ending August 2018, Aurobindo Pharma stated.
The company added that now they have a total of 386 abbreviated new drug application (ANDA) approvals (357 final approvals including 19 from Aurolife Pharma LLC and 29 tentative approvals) from the US FDA.