REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
- Gattex REMS modified (May 27, 2016) to change the sponsor contact information from NPS Pharmaceuticals, Inc. to Shire. To change the REMS appended materials, including updates to a process change in adverse event reporting and the signatory for the Dear Healthcare Provider and Dear Professional Society letters.
- Zinbryta REMS approved (May 27, 2016).
- Probuphine REMS approved (May 26, 2016).
- Entereg REMS modified (May 18, 2016) to remove graphics that bear the Cubist logo in the appended REMS materials and on the REMS website and updates to the REMS appended materials to reflect a change in name of the application owner.
- Vivitrol REMS modified (May 17, 2016) to clarify the implementation date of the communication plan and the timetable for submission of assessments of the REMS.
- Addyi REMS revised (May 10, 2016) to correct a typographical error(s).
- Lotronex REMS revised (April 29, 2016) to change the applications holder’s name or address.
- ER/LA opioid analgesics shared system REMS modified (April 29, 2016) to add Xtampza ER product information to the shared system.
- Thalomid, Revlimid, and Pomalyst REMS modified (April 22, 2016) to change the contact information for emergency contraception information, add flow charts to the Prescriber Guide and the Patient Guide for clarity, add clarifying language to the prescriber enrollment forms about the authorization number, add unacceptable forms of birth control to the Education and Counseling Checklist and Patient Prescriber Agreement Forms (PPAFs), replace “doctor” with “healthcare provider” throughout the PPAF, change the trademark symbols to registered trademark symbols, and insert a “Forgot Password” screenshot in the Celgene Risk Management Website User Guide.