sábado, 15 de abril de 2017

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

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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. Epogen/Procrit and Aranesp REMS released (on April 13, 2017).
  2. Ionsys REMS modified (on March 29, 2017) to align to labeling approved on December 16, 2016 and make additional minor modifications in the REMS document and materials.
  3. Opsumit REMS modified  (on March 21, 2017) to conform with revisions to the approved labeling for Opsumit (macitentan) in the Medication Guide.
  4. Gattex REMS modified (on March 21, 2017) to remove the communication plan as an element of the REMS and maintain the ongoing distribution of the DHCP Letters to prescribers identified as untrained as an activity under the elements to assure safe use
  5. Zinbryta REMS revised (on March 10, 2017)to make an editorial change and correct a typographical error(s).
  6. Symlin REMS released (on March 8, 2017).
  7. Juxtapid REMS revised (on March 2, 2017) to make an editorial change.
  8. Testosterone (ANDA 204255) REMS approved (on February 28, 2017).
  9. Revlimid REMS modified (on February 22, 2017) to include a new indication in the Patient Prescription Forms, Prescriber Guide to REVLIMID REMS Program, Celgene Risk Management.com website, and the Welcome Letter.
  10. Stelara REMS released (on February 15, 2017).
  11. Siliq REMS approved (on February 15, 2017).
  12. Axiron REMS modified (on February 3, 2017) to align the storage temperature listed in the Medication Guide to the storage conditions in other product labeling (i.e. USPI, container label, and carton) and add the statement “Store upright” in the Medication Guide.
  13. Blincyto REMS revised (on January 30, 2017) to make an editorial change.
  14. Xiaflex REMS revised (on January 25, 2017) to correct a typographical error(s).
  15. Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) shared system REMSrevised (on January 23, 2017) to correct a typographical error (s).
  16. Axiron REMS modified (on January 23, 2017) to include an authorized generic in the REMS document and appended materials.

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