lunes, 20 de julio de 2015

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS) website updated

REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
  1. Xyrem REMS modified (on July 15, 2015) to change of the name of the REMS from the “Xyrem Success Program” to “Xyrem REMS Program in the Medication Guide.
  2. Tikosyn REMS modified (on July 8, 2015) to remove the following from the Tikosyn REMS document and REMS appended materials;
    • the requirement for certified pharmacies to utilize a Tikosyn stamp,
    • all references to the Tikosyn stamp, the phrase “…and dispensed for use only with documentation of safe use conditions”,
    • and the REMS document was revised to clarify that the one-time recertification of prescribers and dispensers was required only after initial approval of the REMS.
  3. Victoza REMS modified (on July 1, 2015) to conform the REMS to the safety labeling changes approved on March 9, 2015. The required modifications included a revised REMS document and changes to the following REMS appended materials: REMS Letters, REMS Factsheet, REMS Slides, and REMS webpage.
  4. Testosterone (NDA 202763) REMS revised (on July 1, 2015).

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