The FDA's REMS website, REMS@FDA, has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics shared system REMS modified (on May 26, 2017) to align the REMS document and materials with the labeling approved on December 16, 2016, as well as additional minor modifications.
Vigabatrin shared system REMS revised (on May 24, 2017) to make an editorial change.
Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) shared system REMS modified (on May 23, 2017) to align the REMS document and materials to the labeling approved on December 16, 2016, as well as additional minor modifications.
Saxenda REMS modified (on May 22, 2017) to align with the changes to the Saxenda prescribing information approved with NDA 206321/S-003 on September 22, 2016 in the REMS document and REMS materials.
Caprelsa REMS modified (on May 16, 2017) to:
remove the Medication Guide and the communication plan,
add the Caprelsa REMS Patient Brochure,
add changes to the REMS Document including updates to the goals and change in ownership,
include minor clarifying edits to the following REMS materials to accurately explain the enrollment process and prioritize the presentation of risk information: Caprelsa REMS Prescriber Training Slide Deck, Prescriber Training Pamphlet, Prescriber Training Questions, REMS website screen shots, and Pharmacy Enrollment Form.
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