TURALIO

批准信原文要点

Your proposed modification to the REMS consists of revising the REMS goal and pertinent REMS materials to include vanishing bile duct syndrome as part of the risks the REMS is intended to mitigate to align with the safety information added to the labeling that occurred with the approval of prior approval supplement 013 on January 3, 2025.

批准信原文要点

This Prior Approval sNDA provides for updates to the Boxed Warning, Section 5 Warnings and Precautions, and Section 17 Patient Counseling Information… regarding vanishing bile duct syndrome.

批准信原文要点

This Prior Approval sNDA provides for updates… to include information regarding photosensitivity reactions in Sections 6.1 Clinical Trials Experience and 17 Patient Counseling Information.

批准信原文要点

This Prior Approval supplemental new drug application provides for proposed modifications to the approved Turalio (pexidartinib) risk evaluation and mitigation strategy (REMS). This supplement is in response to our June 21, 2022, REMS Assessment Acknowledgement/REMS Modification Notification letter. … revising the Patient Status Form Question 17 from “Other procedure/referral:” to “Other liver-related procedure/referral:”.

批准信原文要点

This Prior Approval supplemental… provides for the introduction of a 125 mg strength capsule, removal of the 200 mg capsule strength, and updates to… Dosage and Administration, Warnings and Precautions, and Drug Interactions… modifications to the approved TURALIO REMS.

批准信原文要点

This Prior Approval supplemental new drug application provides for an update of the TURALIO Prescribing Information (PI) to include long-term efficacy and safety results in Section 14 and Section 6.

批准信原文要点

This Prior Approval supplemental new drug application updates the TURALIO (pexidartinib) Prescribing Information (PI) adding a new section, 6.2 Postmarketing Experience and stating, “Investigations: blood creatine phosphokinase increased”.

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to the U.S. Prescribing Information adding a new subsection 2.7 Dosage Modification for Hepatic Impairment in addition to updates to the Use in Specific Populations subsection 8.7, Clinical Pharmacology section 12, and Medication Guide to include data for patients with moderate hepatic impairment based on results of study PL3397-A-U129.

批准信原文要点

This Changes Being Effected supplemental new drug application provides for proposed minor modifications to the approved Turalio (pexidartinib) risk evaluation and mitigation strategy (REMS).

批准信原文要点

Your proposed modifications to the REMS consist of changes to the REMS Prescriber Enrollment form, the Patient Enrollment form, and the REMS public web portal to allow the prescriber to delegate administrative REMS tasks, for the applicant to obtain additional information related to safety reports, to allow up to two additional certified prescribers to contribute to patient care and complete REMS documents, and to save REMS forms as pending while waiting for additional information.

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to Sections 2.4 Concomitant Use of Moderate or Strong CYP3A Inhibitors; 5.3 Embryo-Fetal Toxicity; 7.2… 7.3… 8.3… and 12.3 Pharmacokinetics…

批准信原文要点

This new drug application provides for the use of TURALIO (pexidartinib) capsules, 200 mg, for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

批准信原文要点

Your proposed modifications to the REMS consist of changes to the Patient Enrollment Form to clarify instructions and add additional fields.

批准信原文要点

Your proposed modifications to the REMS consist of changes to the Patient Enrollment Form to clarify instructions and add additional fields.