DATE: 26 December 2007
FROM: Basil Golding, MD, Director, Division of Hematology
TO: Jay Epstein, MD, Director, Office of Blood Research and Review
SUBJECT: STN BN070012: FRESENIUS KABI'S NDA FOR 6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INFUSION [VOLUVEN®]
Robert Yetter, Ph.D., Associate Director for Review Management, CBER
Diane Malone, J.D., Associate Director for Policy
The Division of Hematology in the Office of Blood Research and Review reviewed information from this application and determined that referral to the Blood Products Advisory Committee (BPAC) prior to approval was not needed for the following reasons (FDAAA [HR 3580-138 SEC. 918: REFERRAL TO ADVISORY COMMITTEE]):
- Voluven's mechanism of action in the blood as a plasma volume substitute indicated for the treatment and prophylaxis of hypovolemia is well studied and understood.
- Fresenius Kabi has been manufacturing Voluven® since it was approved in Germany in June 1999. Currently, the product is marketed in 66 countries.
- The European-approved Voluven® product manufactured by Fresenius Kabi has demonstrated the benefit of its enhanced pharmacokinetic and safety profile, and its comparable efficacy with other products, particularly with heta- and penta-starch.
- The study design to evaluate efficacy of Voluven® was adequate and the results of the study did not raise any concerns related to safety.
- Review of information submitted in the NDA for Voluven® did not raise any controversial issues or pose unanswered scientific questions which would have benefited from advisory committee discussion and recommendations.
Based on these compelling findings, approval of Voluven® is in the interest of the public health. The content of this memorandum will be incorporated into the action letter on the application.