USFDA approves Zydus Lifesciences to market generic Micafungin injection

The United States Food and Drug Administration (USFDA) has given its approval to market Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials, Zydus Lifesciences Ltd said in an exchange filing.

Zydus Lifesciences said Wednesday it has received the final nod from the US health regulator to market its generic Micafungin injection, which is used to treat a variety of fungal infections.

The United States Food and Drug Administration (USFDA) has given its approval to market Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials, Zydus Lifesciences Ltd said in an exchange filing.

Shares of Zydus Lifesciences were up about a percent to 417.25 rupees on the BSE.


Micafungin for injection is also used to prevent fungal infections in patients who are having a stem cell transplant. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India, the company said.

Micafungin for injection had annual sales of $99 million in the US, according to IQVIA MAT August 2022 data.
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