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Kaizen Biosciences Seeks FDA Approval for Pediatric Antibiotic, Plans to Pursue Commissioner’s National Priority Voucher Program.
ByAinvest
Monday, Jul 14, 2025 10:45 am ET1min read
Kaizen Biosciences has announced multiple abstract acceptances and presented pediatric antibiotic PK data at ISOM. The company is preparing to submit a New Drug Application in September 2025 for its novel amoxicillin-reduced clavulanate formulation. Kaizen is also pursuing the FDA's Commissioner's National Priority Voucher Program, aiming to accelerate the review period and address the public health need for an optimized antibiotic.
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