BLA 761108/S-021
Page 7
| Tanya Wroblewski, MD Associate Director of Therapeutic Review Division of Nonmalignant Hematology Office of Cardiology, Hematology, Endocrinology, and Nephrology Center for Drug Evaluation and Research |
ENCLOSURES:
• Content of Labeling
o Prescribing Information
o Medication Guide
o Instructions for Use
• Carton and Container Labeling
• REMS
U.S. Food and Drug Administration
Silver Spring, MD 20993
www.fda.gov
Reference ID: 5019210
