jueves, 19 de enero de 2017

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

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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. Sodium Oxybate Shared System REMS approved (January 17, 2017).
  2. Adempas REMS modified (January 17, 2017) to include information regarding idiopathic hypertension and switching from a PDE5 inhibitor to Adempas and vice versa in the Medication Guide.    
  3. Soliris REMS modified (January 13, 2017) to align with the changes to the prescribing information related to vaccination in patients receiving Soliris® (eculizumab) in the Medication Guide, and REMS appended materials, including the Dosing and Administration Guide, Patient Safety Brochure, Important Safety Information about Soliris, Prescriber Safety Brochure, Important Safety Information about Soliris, Prescriber Introductory Letter and Enrollment Form, and the Soliris REMS website.      
  4. Zydelig REMS modified (January 4, 2017) to change the REMS materials based on the safety labeling changes approved on September 21, 2016, include the addition of a new risk (fatal and/or serious infections) to the REMS goal statement, and change the timetable for submission of REMS assessments.
  5. Juxtapid REMS modified (January 3, 2017) to make the required modifications outlined in the Safety Labeling Change Notification/REMS Modification Notification letter issued on March 11, 2016 to the REMS document, REMS materials, and a new REMS material named 'Patient Guide and Patient-Prescriber Acknowledgement Form'.
  6. Tracleer REMS modified (December 16, 2016) to: - Add a new form for Veterans Affairs use, 'Tracleer Patient Enrollment and Consent Form – for VA Use'. - Change the Tracleer Patient Enrollment and Consent Form to update the patient consent language and remove non-REMS information in the REMS Website, Dear Healthcare Provider Letter, Prescriber and Pharmacy Guide and REMS Document.
  7. Chantix REMS released (December 16, 2016).
  8. Letairis REMS modified (December 15, 2016) to update the following REMS document and materials including the Letairis REMS; Supporting Document, Prescriber Enrollment and Agreement Form, Prescriber Guide to the Letairis REMS Program, Program Guide for Females Who Can Get Pregnant, Patient Enrollment and Consent Form, Website.
  9. Aveed REMS modified (December 9, 2016) to establish a single shared system REMS for the elements to assure safe use required for the reference listed drug (RLD) Aveed and ANDAs referencing Aveed, called the Testosterone Undecanoate REMS Program, which will become applicable on the date of full approval of the first ANDA referencing Aveed.
  10. Gilenya REMS released (November 29, 2016).                                                                                                                                            
  11. Alosetron REMS modified (November 22, 2016) to reflect the inclusion of an additional ANDA into the alosetron REMS.

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