SYMDEKO (COPACKAGED)

批准信原文要点

We also refer to our letter dated December 4, 2025, notifying you, under Section 505(o)(4) of the FDCA, of new safety information… This information pertains to the risk of psychiatric disorders. … Warnings and Precautions, Neuropsychiatric Events, Including Suicidality / Suicidal Thoughts and Behaviors (5.4).

批准信原文要点

This supplemental new drug application provides for revisions to the labeling for Symdeko, consistent with our June 16, 2025, letter. This information pertains to the risk of increased intracranial pressure disorders.

批准信原文要点

We also refer to our letter dated June 5, 2023, notifying you, under Section 505(o)(4) of the FDCA, of new safety information… This information pertains to the risk of anaphylaxis. This supplemental new drug application provides for revisions to the labeling for Symdeko consistent with our June 5, 2023, letter.

批准信原文要点

This Prior Approval supplemental new drug application provides for an expansion of the indicated Cystic Fibrosis patient population to include additional mutations in the CFTR gene that have been identified as responsive to tezacaftor/ivacaftor based upon in vitro data.

批准信原文要点

This Prior Approval supplemental new drug application provides for an update of the prescribing information in Clinical Pharmacology subsection, “Potential for Tezacaftor/Ivacaftor to affect other drugs,” and Drug Interactions subsections under Section 7.

批准信原文要点

This Prior Approval supplemental new drug application provides for expansion of the indication for the use of tezacaftor/ivacaftor 50 mg/75 mg once daily followed by ivacaftor 75 mg 12 hours later for patients < 30 kg, and tezacaftor/ivacaftor 100 mg/150 mg once daily followed by ivacaftor 150 mg 12 hours later for patients ≥ 30 kg, for the treatment of cystic fibrosis in patients aged 6 to less than 12 years old who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.