BALVERSA

批准信原文要点

This Prior Approval sNDA provides for… Updates to the Pediatric Use subsection (8.4) to include clinical and safety information regarding skeletal toxicities in pediatric patients.

批准信原文要点

This “Changes Being Effected” sNDA provides for adding the sentence “If the phosphate level is 9.0 mg/dL or higher follow the relevant dose modifications in Table 2” in section 2.2 of the Dosage and Administration section of the USPI in order to strengthen the instruction for dosage and administration that is intended to increase the safe use of Balversa and add “after up-titration” to hyperphosphatemia in Table 2 to clarify the guidance for up-titration.

批准信原文要点

Please see information on the two supplements below: • NDA 212018/S-008: SE-7 Accelerated Approval Confirmatory Study (Subpart H) • NDA 212018/S-009: SE-1 New Indication or significant modification to existing indication Supplement 007 provides for: 1.

批准信原文要点

Please see information on the two supplements below: • NDA 212018/S-008: SE-7 Accelerated Approval Confirmatory Study (Subpart H) • NDA 212018/S-009: SE-1 New Indication or significant modification to existing indication Supplement 007 provides for: 1.

批准信原文要点

Supplement 007 provides for: 1. Updated information on the effect of erdafitinib on the pharmacokinetics (PK) of midazolam and metformin, as well as potential drug-drug interaction (DDI) with CYP2C9 inducers or strong CYP3A4 inducers... 2. Addition of hyponatremia and blood creatinine increased as adverse reactions.

批准信原文要点

This “Changes Being Effected” sNDA provides for a revision to Table 4 of the Prescribing Information to change the term “Fasting glucose increased” to “Fasting glucose decreased”.

批准信原文要点

This Prior Approval sNDA provides for revisions to the Adverse Reactions section… Table 3… change the term “onycholysis” to “nail disorder” and to include “onycholysis” and “onychomadesis” in the nail disorder footnote.

批准信原文要点

Prior Approval sNDA 003 provides for updates to the Warnings and Precautions section, Hyperphosphatemia sub-section to add “soft tissue mineralization, including calciphylaxis” to the existing warning and make corresponding changes throughout the Prescribing Information and Patient Package Insert in response to the FDA Supplement Request letter dated November 19, 2021.

批准信原文要点

Prior Approval sNDA 002 provides for updates to the Clinical Pharmacology section, Pharmacokinetics/Specific Populations sub-section based on results from Study 42756493EDI1008 entitled “A Phase1, Open-Label, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib”.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following updates to the labeling as requested by the agency in the December 19, 2019, Prior Approval Supplement Request letter: • In Highlights and other corresponding sections of the label, “Strong CYP2C9 and CYP3A4 inhibitors” has been changed to “Moderate CYP2C9 or strong CYP3A4 inhibitors”