Zydus Lifesciences gets final approval from USFDA for Azithromycin tablets

The drug will be manufactured at the group's formulation manufacturing facility at Moraiya in Ahmedabad, Zydus said. (Representative Image)

Zydus Lifesciences Ltd on Monday said it has received final approval from the US health regulator to manufacture and market its generic version of Azithromycin tablets used in the treatment of certain bacterial infections.

The approval by the US Food and Drug Administration (USFDA) is for manufacturing and marketing of Azithromycin tablets 500 mg strength, Zydus Lifesciences said in a regulatory filing.

The drug will be manufactured at the group's formulation manufacturing facility at Moraiya in Ahmedabad, it added.

Azithromycin is indicated to treat certain bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STD), infections of the ears, lungs, sinuses, skin, throat, and reproductive organs, the company said.

Azithromycin tablets 500 mg had annual sales of USD 20 million in the US, it said citing IQVIA MAT February 2023 data.