Jun 11: Hyderabad-based drug maker Aurobindo Pharma Ltd on Wednesday announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Azithromycin tablets 250 mg and 500 mg. Azithromycin tablets are an AB-rated generic equivalent of Pfizer Inc’s Zithromax tablets.
The product will be launched in July 2018, according to the company.
“Azithromycin tablets are indicated for the treatment of patients with mild to moderate infections. The approved product has an estimated market size of $132 million for the twelve months ending May 2018 according to IQVIA,” it said.
This is the 146th ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 377 ANDA approvals (344 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.