Zydus gets USFDA's final nod to market antifungal Micafungin for injection

Ahmedabad (Gujarat) [India], October 26 : Zydus Lifesciences on Wednesday said it received approval from the US Food and Drug Administration (USFDA) to market Micafungin for injection of 50 mg/vial and 100 mg/vial as single-dose vials in the US.
The pharma firm, formerly known as Cadila Healthcare, said 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.
The pharma firm said Micafungin for injection had annual sales of USD 99 million in the United States, according to IQVIA data.
The group now has 329 approvals and has so far filed over 428 abbreviated new drug applications (ANDAs) since the commencement of the filing process in the financial year 2003-04, the pharma firm said.
Micafungin is an antifungal agent used for the treatment of candidemia, acute disseminated candidiasis, and certain other invasive Candida infections, and for the prophylaxis of Candida infections during stem cell transplantation.