USFDA approves Zydus Lifesciences anti-fungal injection

HPV vaccine

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

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