GESTIÓN EN SALUD PÚBLICA: Summary of REMS@FDA Website Updates for March and April, 2020

domingo, 10 de mayo de 2020

Summary of REMS@FDA Website Updates for March and April, 2020

1. Suboxone/Subutex REMS modified March 2 to make changes to the REMS Document to the new format in accordance with the October 2017 Draft Guidance: Format and Content of a REMS Document Guidance for Industry.

2. Myalept (metreleptin) REMS revised March 13 to make editorial changes.

3. Soliris (eculizumab) REMS modified April 7 to reflect revisions to the Prescriber Enrollment Form to include prescriber specialty.

4. Opsumit (macitentan) REMS modified April 8 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) Opsumit and ANDAs referencing Opsumit, called the Macitentan REMS Program, which will become applicable on the date of full approval of the first ANDA joining a shared system with Opsumit. The modification results in a two-part REMS consisting of: (1) the requirements of the previously approved Opsumit REMS, and (2) the new SSS REMS for macitentan products. The requirements of the previously approved Opsumit REMS will remain applicable until full approval of the first ANDA joining a shared system with Opsumit, at which time, they will automatically be replaced by the requirements of the single, shared system.

5. Zyprexa Relprevv (olanzapine) REMS modified April 22 to make changes to the Zyprexa Relprevv Patient Care Program Instructions Brochure to align with recent approved changes to the U.S. Prescribing Information (USPI) and the Medication Guide (MG).

6. Ambrisentan Shared System REMS. On April 20 the PS-Ambrisentan SS REMS, comprised of two ANDAs, merged with the Ambrisentan SS REMS.

7. Tysabri (natalizumab) REMS

modified April 21 to update the REMS document and REMS materials to align with updates to the Indications and Usage section. Updates to the Infusion Site Enrollment Form and Certified Pharmacy Enrollment Form to include statements about the authorized representative and contact information for certified infusion sites and pharmacies, respectively. Updates to the list of other therapies for multiple sclerosis that should be avoided for use with Tysabri. In addition, revision of the 6-Month Discontinuation Form – Crohn’s Disease (CD) to align it with the multiple sclerosis (MS) version of this form and revision of "Full Prescribing Information" and “Boxed Warning” throughout all appended REMS materials to "Prescribing Information" and “BOXED WARNING.
revised April 27 to make an editorial change.

8. Ultomiris (ravulizumab-cwvz) REMS modified April 30 to make changes to the Prescriber Enrollment Form to include the prescriber specialty and reformat this form from two pages to one page.

9. Opioid Analgesic REMS added the following: