Zydus Lifesciences gets FDA final approval for Micafungin for Injection

Zydus Lifesciences (formerly Cadila Healthcare) has secured final approval for Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials from the US Food and Drug Administration (FDA).

The product is the generic version of Mycamine, and has approval for the treatment of a range of fungal infections. Besides, Micafungin for Injection, 50 mg/vial and 100 mg/vial is indicated to be used for the prevention of fungal infections in patients who are having a stem cell transplant.

Zydus Lifesciences gets FDA final approval for Micafungin for Injection. Photo courtesy of Zydus Cadila.

Zydus Lifesciences will manufacture the Mycamine generic product at its injectable manufacturing factory in Jarod, near Vadodara.

As per IQVIA MAT Aug 2022, Micafungin for Injection had yearly sales of $99 million in the US.

Zydus Lifesciences has taken its approvals to 329 now and has to date filed more than 428 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.