AUSTEDO

批准信原文要点

This Prior Approval sNDA provides for proposed labeling changes in Section 12.3 (Pharmacokinetics), to reflect new data on deutetrabenazine protein binding and drug interaction studies.

批准信原文要点

These “Changes Being Effected” sNDAs provide for aligned labeling with the Austedo XR sNDA 216354/S-006 approved on May 29, 2024, and sNDA 216354/S-007 approved on July 1, 2024.

批准信原文要点

These “Changes Being Effected” sNDAs provide for aligned labeling with the Austedo XR sNDA 216354/S-006 approved on May 29, 2024, and sNDA 216354/S-007 approved on July 1, 2024.

批准信原文要点

This “Changes Being Effected” sNDA provides for updated Prescribing Information (PI) and Mediation Guide under NDA 208082 (Austedo) to align with the combined labeling that was approved under NDA 216354 (Austedo XR).

批准信原文要点

This Prior Approval sNDA provides for proposed labeling changes in Section 2.1 Dosing Information and in the highlights to provide for changing the starting dose for patients with chorea associated with Huntington’s disease to 12 mg/day.

批准信原文要点

This Prior Approval supplemental new drug application provides for labeling changes to section 8.4 (Pediatric Use), obtained from studies completed in response to our Written Request issued January 8, 2020, regarding the use of deutetrabenazine in patients age 6 to 16 for the treatment of Tourette Syndrome. These changes include description of studies conducted, relevant safety information, and description of juvenile animal toxicity data.

批准信原文要点

This Prior Approval supplemental new drug application provides for addition of a new physician sample package configuration that expands the currently approved 2-week titration pack to include a 4-week titration kit.

批准信原文要点

This Prior Approval supplemental new drug application provides for labeling changes in Section 2.1 (Dosing Information), Section 5.3 (QTc Prolongation), Section 7.2 (Drugs that Cause QTc Prolongation), Section 12.2 (Pharmacodynamics), and the Medication Guide.

批准信原文要点

This supplemental new drug application provides for revisions to the labeling for Austedo, consistent with our April 3, 2019, Safety Labeling Change Notification letter.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for an update to NDA 208082, approved April 3, 2017, for treatment of chorea associated with Huntington’s disease, with the Austedo Prescribing Information approved by the Division of Psychiatry Products …