ONPATTRO

批准信原文要点

This Prior Approval supplemental new drug application provides for changes to the clinical pharmacology section (12.2 Pharmacodynamics and 12.3 Pharmacokinetics) of the prescribing information for Onpattro based on data from an open-label study in patients with prior liver transplantation.

批准信原文要点

This “Changes Being Effected” sNDA proposes a change to Section 6.1 (Clinical Trials Experience) to include information about the reduction in vitamin A levels after exposure to Onpattro.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for updates to subsection 5.1 (Infusion-Relation Reactions) and adds subsection 6.3 (Postmarketing Experience) to the Onpattro prescribing information.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for the addition of the phone number and email of the ongoing pregnancy exposure registry in Section 8.1 – Pregnancy of the labeling for Onpattro.

批准信原文要点

This Prior Approval supplemental new drug application provides for revised labeling in the Clinical Pharmacology section of the Prescribing Information (Section 12.3 – Drug Interaction studies) pursuant to completed in vitro drug interaction studies.