Zydus gets US FDA nod for antibiotic drug Azithromycin
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Indian pharma company Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to manufacture and market antibiotic Azithromycin used to treat bacterial infections, the company announced on Monday.
"Zydus Lifesciences Limited (including its subsidiaries/affiliates) has received final approval from the US Food and Drug Administration (FDA) to manufacture and market Azithromycin tablets USP, 500 mg," the company said in a statement.
Azithromycin is used 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 drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company said.
In the US, Azithromycin tablets USP, 500 mg had annual sales of $20 million, it said citing IQVIA MAT February 2023 data.
