Date: June 1, 2011
From: Yiping Jia, Committee ChairSubject: Summary Basis for Regulatory Action
Applicant: Kedrion, S.p.A.Date of Submission: August 3, 2010
PDUFA Goal Date: June 3, 2011Proprietary Name / Established (USAN) names: KEDBUMIN / Albumin (Human)
Dosage forms: 25% 50 mL in --(b)(4)-- glass bottlesProposed 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).
- 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: ApprovalSignatory Authority(ies) Action
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