REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
- Kynamro REMS modified (on July 28, 2015) to;
- change the trademark symbol (TM) to a registered symbol (R) throughout the appended REMS materials, and to
- add an updated logo that includes “200 mg/mL” to the appended REMS materials; and to
- update the email address used to conduct REMS functions throughout the REMS materials, and to add a scan and email option for submitting the Prescription Authorization Form.
- Tanzeum REMS modified (on July 27, 2015) to conform to the REMS to the safety labeling changes approved on March 9, 2015 under sBLA No. 008. The required modifications include changes to the REMS document and to the following REMS appended materials: REMS Letter for Healthcare Providers, REMS Letter for Professional Societies, REMS Factsheet, and the REMS Webpage.
- Trulicity REMS modified (on July 27, 2015) to conform the REMS to the safety labeling changes approved on March 9, 2015, in sBLA No.001. The required modifications included a revised REMS document and changes to the following REMS appended materials: REMS Letters, REMS Factsheet, and REMS webpage.
- Lotronex REMS modified (on July 24, 2015) to change the REMS document and appended materials to include an authorized generic, alosetron hydrochloride.