REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
- 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.
- 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.