Rigel Pharmaceuticals Inc (RIGL)

[chitre]

To CEO Raul R. Rodriguez


From: CDER DRUG INFO <[e-mail]>
Sent: Thursday, November 15, 2018 12:31 PM
To: esteban charpentier
Subject: RE: TAVALISSE

Thank you for writing the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.

We are sorry to learn of your experince with Tavalisse. The approved albeling for Tavalisse can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209299lbl.pdf. Chest pain was reported in 6% of patients.

You can report adverse effects to the FDA through the MedWatch reporting program. It is a voluntary system of reporting to FDA any adverse events such as the one you have experienced. You can find a link to the MedWatch online voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/Safety/MedWatch/default.htm), click on the button, “Report a Problem”, choose Consumer and follow the instructions.


Best regards,
BR
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
[e-mail]