Ionetix receives FDA approval for Gallium Ga-68 gozetotide (PSMA-11) ANDA

Ionetix Corp / DE /

FDA approved Ionetix's Abbreviated New Drug Application for Gallium Ga-68 gozetotide, a PET diagnostic agent.
First commercial drug manufacturer to receive ANDA approval for this drug.
Indicated for PSMA-PET imaging to detect prostate cancer lesions in men with suspected metastasis or recurrence.
Product supplied as single-dose capped syringe (~8-10mL) with three-hour expiration from end of synthesis.
Expands Ionetix's portfolio in PET diagnostics; company plans to serve underserved areas via existing multi-site PET facility network.

item 7.01 item 9.01

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