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Zydus receives final approval from the USFDA for Micafungin for Injection

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 (USRLD: Mycamine®). Micafungin for

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 (USRLD: Mycamine®).

Micafungin for Injection is indicated to treat 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 USD 99 mn 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.

medgatetoday@gmail.com

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