Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture Azithromycin tablets 250 mg and 500 mg.
Announcing this, the company said the product would be launched this month. The approved product has an estimated market size of $132 million for the 12 months ended May 2018, a release from Aurobindo said citing IQVIA figures.
Azithromycin tablets are an AB-rated generic equivalent of Pfizer's Zithromax tablets and are indicated for the treatment of mild to moderate infections.
This is the 146th ANDA, including 19 tentative approvals, to be approved out of Aurobindo Pharma's Unit VII formulation facility in Hyderabad that is 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.