FDA Tentative Approval: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

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Summary

The FDA granted tentative approval for a supplemental application for Mycamine (micafungin sodium) from Astellas Pharma US, enabling potential marketing under r…

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Diseases / indications

• Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation
• Candidemia
• Disseminated Candidiasis
• Invasive Candidiasis

Drugs mentioned

• Mycamine (Micafungin)

Snippet

SUPPL TA for MYCAMINE (MICAFUNGIN SODIUM)