FDA accepts Shionogi sNDA for Fetroja pediatric use in serious Gram-negative infections

• FDA accepted Shionogi’s supplemental NDA to expand Fetroja use to pediatric patients for HABP/VABP, cUTI, including pyelonephritis.
• Regulatory decision deadline set for Feb. 23, 2027 under the PDUFA review timeline.
• Filing backed by data from three studies in 154 children from birth to under 18 years.

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