Summary of REMS@FDA Website Updates for March and April, 2019

Summary of REMS@FDA Website Updates for March and April, 2019

1. Jynarque REMS revised March 4, 2019 to reflect editorial changes.

2. Spravato REMS approved March 5, 2019.

3. Opioid Analgesic Shared System REMS added ANDA #211023, March 8, 2019.

4. Zulresso REMS approved March 19, 2019.

5. Ambrisentan Shared System REMS modified March 28, 2019 to establish a Single Shared System (SSS) REMS for the elements to assure safe use and the implementation system required for the reference listed drug (RLD) Letairis and ANDAs referencing Letairis, called the Ambrisentan REMS Program.

• Added ANDA #208354 and ANDA #209509 April 10, 2019.

6. PS-Ambrisentan Shared System REMS approved March 28, 2019.

• Added ANDA #210715 April 26, 2019.

7. Addyi REMS modified April 2, 2019 to add a digital version of the REMS Patient-Provider Agreement Form (PPAF).

8. Testosterone REMS (ANDA #204570) approved April 10, 2019.

9. Testosterone REMS (ANDA #208560) approved April 10, 2019.

10. Testosterone REMS (ANDA #208620) approved April 10, 2019.

11. Testosterone REMS (ANDA #207373) approved April 10,2019.

12. Mifepristone Shared System REMS modified April 11, 2019 to establish a Single Shared System REMS for the elements to assure safe use and the implementation system required for the reference listed drug (RLD) Mifeprex and ANDAs referencing Mifeprex, called the Mifepristone REMS Program.

13. Zyprexa Relprevv REMS modified April 11, 2019 to remove Important Safety Information references within the Patient Care Program Website and to update the Prescribing Information in the Patient Care Program Instructions Brochure.

14. Blincyto REMS modified April 18, 2019 to add instructions in the REMS letters and Fact Sheet to administer corticosteroids for severe or lifethreatening CRS.

15. Yescarta REMS modified April 19, 2019 to clarify the severity of adverse events (AEs) suggestive of cytokine release syndrome (CRS) and neurological toxicities that must be reported and to change the timing of distribution of the Patient Wallet Card to the patient. These modifications resulted in corresponding updates to the REMS materials.

16. Lemtrada REMS modified April 23, 2019 to change the goals of the REMS from “to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA” to “to mitigate the risks of autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA.” Revisions to the appended materials to incorporate information about the risk of autoimmune hepatitis, reflecting labeling changes approved on January 16, 2019.

17. Bosentan Shared System REMS modified April 26, 2019 to establish a Single Shared System REMS for the elements to assure safe use and the implementation system required for the reference listed drug (RLD) Tracleer and ANDAs referencing Tracleer, called the Bosentan REMS Program. This modification also removes the Medication Guide as an element of the REMS.