martes, 2 de mayo de 2017

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS) website update

fda header

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. Vigabatrin shared system REMS approved (on April 27, 2017).
  2. Truvada REMS modified (on April 21, 2017) to:
    1. update the REMS materials to align with the U.S. Package Insert including removal of the class labeling boxed warning for lactic acidosis/severe hepatomegaly with steatosis, removal of fat redistribution from the warnings and precautions, and incorporating drug-drug interaction data with Epclusa (sofosbuvir/velpatasvir) and Descovy (emtricitabine/tenofovir alafenamide)
    2. make editorial changes to the REMS Document and REMS Supporting Document to reflect completion of the requirement to publish the Journal Information Piece for 3 years following initial approval of the REMS.
  3. Probuphine REMS modified (on April 19, 2017) to make modifications to the Probuphine REMS Program Surgical Procedures Recertification Transcript.
  4. Trulicity REMS revised (on April 19, 2017) to make editorial changes.
  5. Transmucosal Immediate-Release Fentanyl (TIRF) Products shared system REMS  modified (on April 11, 2017) to add the authorized generic and a Medication Guide that is identical to that of the branded product, except that only the authorized generic (fentanyl buccal tablets) is listed as the product name.

No hay comentarios:

Publicar un comentario