Summary of REMS@FDA Website Updates for May and June, 2019

1. Gattex REMS modified May 16, to align the REMS materials with the approval of an efficacy supplement, including incorporating information about the new population, which expands usage to include pediatric patients 1 year of age and older with SBS who are dependent on parenteral support, into the existing REMS. Modified to make formatting and editorial changes, typographical corrections, and administrative changes throughout the REMS document and all REMS materials.

2. Blincyto REMS revised May 16, to make an editorial change.

3. Zulresso REMS modified May 17, to align the pregnancy information in the Zulresso REMS materials (Patient Information Guide and Training for Healthcare Settings) with the approved Prescribing Information (PI) and Medication Guide (MG). Revised June 17 to Make an editorial change.

4. Bosentan Shared System REMS revised May 20, to make an editorial change.

5. Revlimid REMS modified May 28, to remove indication statements from REMS materials,convert the REMS document into the current template and remove prescription forms from the REMS.

6. Testosterone topical product REMS released May 30.

7. Vigabatrin Shared System REMS modified May 30, to allow for the continuation of therapy for patients currently enrolled in the Vigabatrin REMS by an uncertified prescriber in the inpatient setting, and incorporating the requirement that a certified prescriber must authorize additional vigabatrin dispenses for these patients within 15 days of inpatient admission. The REMS document and Pharmacy Enrollment Form were revised to align with these changes. The REMS document was also revised to align with the Format and Content of a REMS Document Guidance for Industry.

8. Adempas REMS revised May 30, to make an editorial change.

9. Vivitrol REMS modified June 7, to update the language in the Dear Healthcare Provider letter to remove the terms “new,” “recent,” and “now,” when discussing safety information that was added in 2015, and to change the signatory on the letter.

10. Opsumit REMS modified June 10, to update the REMS document and REMS materials to require the inpatient pharmacy Authorized Representative (AR) to notify the Opsumit REMS when the AR changes.

11. Juxtapid REMS revised June 13, to update the corporate address.

12. Opioid Analgesic REMS added tramadol hydrochloride, ANDAs 202075 and 208708.

13. Spravato REMS modified June 25, to amend some of the data-capturing fields in the Healthcare Setting Enrollment Form, Pharmacy Enrollment Form, and Patient Monitoring Form.

14. Siliq REMS revised June 27,  to reflect the new company name.