Summary of REMS@FDA website updates for January and February 2019

Summary of REMS@FDA website updates for January and February 2019

1. Clozapine Shared System REMS modified January 16, 2019 to incorporate the addition of educational materials, changes to the inpatient prescriber certification requirements and patient monitoring, and initiating the operational restrictions for prescriber and pharmacy certification. 2. Opsumit (macitentan) REMS  modified February 1, 2019 to add provisions for prescribers to enroll patients in the Opsumit REMS online and by phone, add descriptions of the new patient enrollment processes in the REMS materials, add a description for the process of how prescribers and pharmacies enroll by phone in the REMS materials, and add an option for prescribers to report a change in the patient's reproductive status by phone in the Opsumit REMS. 3. Blincyto (blinatumomab) REMS revised February 5, 2019 to make editorial changes.  4. Omontys (peginesatide) withdrawal of approval, February 13, 2019. 5. Opioid Analgesic Shared System REMS added the following: ANDA 211228 methadone hydrochloride, January 3, 2019 ANDA 210758 oxycodone hydrochloride, January 24, 2019 ANDA 204785 acetaminophen, caffeine, and dihydrocodeine bitartrate, January 29, 2019 ANDA 206914 oxycodone hydrochloride, February 1, 2019 ANDA 211749 oxycodone hydrochloride, February 4, 2019 ANDA 89673 acetaminophen and codeine phosphate, February 4, 2019 ANDA 211748  oxycodone hydrochloride, February 7, 20196.  6. Alosetron Shared System REMS added ANDA 209180 January 14, 2019. 7. Vigabatrin Shared System REMS added ANDA 209822 January 14, 2019.  8. Suboxone/Subutex (buprenorphine and naloxone) REMS added ANDA 205954 January 24, 2019. 9. Mycophenolate Shared System REMS added ANDA 210370 February 12, 2019.