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Zydus gets US FDA nod for antibiotic drug azithromycin

IANS Apr 11, 2023

Indian pharma company Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to manufacture and market the antibiotic azithromycin used to treat bacterial infections, the company announced on April 10.


"Zydus Lifesciences Limited (including its subsidiaries/affiliates) has received final approval from the US Foods 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), and 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.

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