jueves, 3 de mayo de 2018

Summary of REMS@FDA website updates for March and April, 2018

1. Sublocade (buprenorphine extended-release) REMS revised March 8, 2018 to reflect 
editorial changes. 

2. Zydelig (idelalisib) REMS modified March 22, 2018 to change the REMS materials based 
on updated incidence rates of fatal and serious toxicities in the Boxed Warning.

3.Blincyto (blinatumomab) REMS modified March 29, 2018 to include safety data and a new 
indication to the REMS materials; modified April 10, 2018 to align with prescribing 
information changes.

4.Tysabri (natalizumab) REMS modified April 18, 2018 to:
  • Change selected REMS materials to reflect the addition of information noting that the isk of developing PML may be associated with relative levels of serum anti-JCV antibody compared to a calibrator as measured by ELISA (often described as an anti-JCV antibody index value). This information has been included in the TOUCH Prescribing Program Educational Slide Deck, and the following statement has been added to selected REMS forms (the Prescriber/Patient Enrollment Forms, the Patient Status Report and Reauthorization Questionnaires, the Initial Discontinuation Questionnaires, and the 6- Month Discontinuation Questionnaire [MS]): “If an anti-JCV antibody index value is available, please record it here:__”.
  • Removal of 12-Week Questionnaire for Crohn’s Disease from the REMS.
  • Changes to REMS educational materials to align with labeling changes approved on August 16, 2017, pertaining to JCV granule cell neuronopathy, MRI monitoring for PML, anti-JCV antibody testing following use of intravenous immunoglobulin, and acute etinal necrosis caused by herpes viruses.
  • Minor formatting changes and editorial revisions.
Revised April 30, 2018 to reflect editorial changes.

5. Jynarque (tolvaptan) REMS approved April 23, 2018.

6. Isotretinoin iPLEDGE Shared System REMS modified April 23, 2018 to add a new sponsor, remove a product name (which is no longer available), update a name change for a sponsor, bold text to highlight “The Do Not Dispense After Date”, replacing radio buttons and a table with drop down menus and editorial changes for consistency by  aligning the list of birth control methods options with the listing on the approved Birth Control Information Sheet.

10. Vigabatrin Shared System REMS added ANDA's 209824 and 210155.

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