Vaccines, Blood & Biologics

Summary Basis for Regulatory Action, June 1, 2011 - Kedbumin

Date: June 1, 2011

From: Yiping Jia, Committee Chair 

Subject: Summary Basis for Regulatory Action

BLA #STN
Supplement# 125384/0

Applicant: Kedrion, S.p.A.

Date of Submission: August 3, 2010

PDUFA Goal Date: June 3, 2011

Proprietary Name / Established (USAN) names: KEDBUMIN / Albumin (Human)

Dosage forms: 25% 50 mL in --(b)(4)-- glass bottles

Proposed Indication(s):

- Hypovolemia: Restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate.
- Hypoalbuminemia: When the albumin deficit is the result of excessive protein loss, the effect of albumin administration will be temporary unless the underlying disorder is reversed.
- Prevention of central volume depletion after paracentesis due to cirrhotic ascites.
- Ovarian hyperstimulation syndrome (OHSS).
- Adult Respiratory Distress Syndrome (ARDS).
- Burns
- Hemodialysis: For patients undergoing long term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.
- Cardiopulmonary Bypass Procedures: As part of the priming fluid.

Recommended Action: Approval

Signatory Authority(ies) Action

Jay Epstein____________________________
Offices Signatory Authority:
I concur with the summary review
I concur with the summary review and include a separate review or addendum to add further analysis
I do not concur with the summary review and include a separate review or addendum

Page Last Updated: 01/26/2016
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