lunes, 24 de octubre de 2016

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. Tysabri REMS revised (October 14, 2016) to correct a typographical error(s).

2. Adempas REMS modified (October 4, 2016) to:
  • Remove non-REMS related information from the Adempas REMS Patient Enrollment and Consent Form.
  • Eliminate the VA REMS Patient Enrollment and Consent Form.
  • Add the word “REMS” to the title of the following forms: Adempas REMS Patient Enrollment and Consent Form and Adempas REMS Patient Enrollment and Consent Form.
3. Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) shared system REMS modified (October 4, 2016) to include the proposed new strength into the Dose Comparison Chart included in both the Prescriber Brochure, "Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers" and the Pharmacist Brochure, "Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists."

4. Extended-Release and Long-Acting (ER/LA) Opioid Analgesics shared system REMS modified (September 30, 2016) to to relocate the product-specific information section from the Blueprint for Prescriber Education to the FDA website located at
5. Natpara REMS modified (September 29, 2016) to add an online prescriber certification process.
6. Adasuve REMS modified (September 28, 2016) to:
  • Change the goal of the Adasuve REMS.
  • Change the prescriber and healthcare setting attestations, and requirements for certified healthcare settings.
  • Update the REMS materials to reflect the supplies and personnel that a certified healthcare setting must now have available to manage acute bronchospasm.
  • Remove the communication plan as an element of the REMS.
  • Update to reflect the change in ownership from Teva Pharmaceuticals to Alexza Pharmaceuticals, Inc.
  • Update the implementation system to clarify your (Alexza Pharmaceuticals, Inc.) responsibilities.
7. Tysabri REMS modified (September 22, 2016) to:
  • Change the REMS to be consistent with safety labeling changes approved on May 18, 2016. The approved safety labeling change included the addition of “Periodic monitoring for radiographic signs consistent with PML should be considered to allow for an early diagnosis of PML. Lower PML-related mortality and morbidity have been reported following Tysabri discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis” within Section 5.1—Progressive Multifocal Leukoencephalopathy of the prescribing information. 
  • Change the sponsor name change from Biogen Idec to Biogen in the REMS document and all REMS materials.
  • Update the list of immunosuppressants, antineoplastics, and immunomodulators with a recently approved medication for multiple sclerosis (Zinbryta [daclizumab]) in the REMS materials.
  • Change the signature statements to enable certified prescribers to delegate the completion of the forms to individuals within their office who are not certified prescribers in the reauthorization and discontinuation status forms.
  • Make format and editorial changes, typographical corrections, and update version and copyright dating throughout the REMS materials.
  • Delete the REMS call center hours of availability from all REMS materials.
8. Victoza REMS modified (September 20, 2016) to add a REMS-specific link on all Victoza (liraglutide) consumer websites to improve healthcare providers’ access to the Victoza REMS.
9. Blincyto REMS modified (August 30, 2016) to change the communication plan to include the distribution of the REMS Letter for Professional Societies to pediatric-related professional societies and organizations, updates to the REMS materials to incorporate the changes to the prescribing information, and other minor formatting and editorial changes.
10. Bupropion (ANDA 206122) REMS approved (August 17, 2016).
11. Chantix REMS modified (August 12, 2016) to add new language describing a reduce-to-quit regimen and to provide information about the risk of somnambulism so as to furnish adequate information for the safe and effective use of the drug in the Medication Guide.

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