USFDA approves Zydus Lifesciences anti-fungal injection
HQ Team
October 26, 2022: Zydus Lifesciences announced that it had received final approval from the USFDA to market Micafungin for injection, according to a BSE filing.
The injections are in single-dose vials of 50mg and 100mg. They prevent a variety of fungal infections.
It also prevents fungal infections in patients with a stem cell transplant.
The drug will be made at the company’s injectable manufacturing facility at Jarod, near Vadodara, India.
$99 million market
Micafungin for injection had annual sales of $99 million in the US, according to IQVIA data. The group has 329 approvals and has filed over 428 ANDAs as of June 2022.
IQVIA is a global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
An abbreviated new drug application or ANDA contains data submitted to the FDA for a generic drug product’s review and potential approval.
Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references
