Summary of REMS@FDA website updates for July & August 2017

The FDA's REMS website, 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. Vogelxo REMS revised (on August 11, 2017) to change the application holder’s name or address.

2. Testosterone (ANDA 205328) REMS approved (on August 7, 2017).

3. Natpara REMS revised (on August 8, 2017) to change the application holder’s name or address

4. Letairis REMS modified (on July 21, 2017) to update the Letairis REMS Patient Enrollment and Consent Form.

5. Blincyto REMS modified (on July 12, 2017) to incorporate the proposed changes to the Prescribing Information and make other minor edits to the REMS materials.

6. Testosterone 1.62% (ANDA 205781) REMS approved (on July 12, 2017).

7. Qsymia REMS revised (on July 3, 2017) to make editorial changes.