viernes, 8 de diciembre de 2017

Summary of REMS@FDA website for November, 2017

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):

1.   Zinbryta (daclizumab) modified 11/01 to: 
  • Add a secured web-based tool to complete prescriber certification and enrollment and patient enrollment and monitoring online.
  • Make editorial changes to the REMS document.
  • Change the REMS materials to conform to the safety labeling changes pertaining to the risks of hepatic injury and immune mediated reactions that were approved on August 28, 2017.

2. Zyprexa Relprevv (olanzapine) modified 11/30 to update various appended REMS materials.

3. Sublocade (buprenorphine extended-release) injection (NDA 209819) approved 11/30.

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