Summary of REMS@FDA Website Updates for July & August, 2019

Summary of REMS@FDA Website Updates for July & August, 2019

1. Emtricitabine/tenofovir disoproxil fumarate Shared System REMS released July 1, 2019.
2. Kynamro NDA 203568 withdrawn July 3, 2019.
3. Ionsys NDA 021338 withdrawn July 3, 2019.
4. Opioid Analgesic REMS added morphine sulfate tablets, ANDA 210610 on July 22, 2019 and methadone hydrochloride oral concentrate, ANDA 207368 on August 22, 2019.
5. Yescarta REMS modified August 2, 2019 to update REMS materials to ensure they are aligned with the recently approved USPI (May 2019) and the recently approved major modification to the REMS for Yescarta (April 2019).
6. Alosetron Shared System REMS revised August 5, 2019 to remove individual applicant names from website screenshots.
7. Turalio REMS revised August 20, 2019 to reflect editorial changes