Zydus receives final approval from USFDA for Micafungin for Injection

Zydus receives final approval from USFDA for Micafungin for Injection

By: IPP Bureau

Last updated : October 26, 2022 9:46 am



Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials.

Micafungin for Injection is indicated to treat a variety of fungal infections. It 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.

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).

The group now has 329 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited USFDA

First Published : October 26, 2022 12:00 am