lunes, 6 de noviembre de 2017

Summary of REMS@FDA website updates for October, 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. Adasuve REMS revised to change the application holder’s name or address.

2. Yescarta REMS approved October 18, 2017.

3. Tracleer REMS modified (on October 20, 2017) to change the approved Tracleer REMS document to add an authorized generic for Tracleer Tablets (NDA 21290).

4. Vigabatrin REMS modified (on October 23, 2017) to make changes to the website screenshots that include the addition of language that will prevent the need for a REMS modification each time an ANDA is added and/or removed from the REMS, and/or a pharmacy is added to, or removed from the list of certified pharmacies. 

5. testosterone REMS (ANDA 208061) approved October 23, 2017.

6. Soliris REMS modified (on October 23, 2017) to make editorial changes to the REMS document and changes to the REMS appended materials to align with labeling changes related to the new indication.

7. Kynamro REMS modified (on October 25, 2017) to make changes to the REMS document and existing REMS materials and to add the following new REMS materials: Patient Guide and Patient-Prescriber Acknowledgment Form. 

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