Product Approval Information - New Drug Applications
Product name: 6% Hydroxyethyl Starch in 0.9% Sodium Chloride Infusion (Voluven® 500 mL freeflex® flexible plastic intravenous solution container)
Manufacturer: Fresenius Kabi Norge A.S., Halden Norway
Intended Use: Treatment and prophylaxis of hypovolemia
Approval Date: 12/27/2007
Type of submission: New Drug Application
NDA Number: BN070012
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Approval information/letter/labeling
Memorandum/Reviews
- Approval Memorandum
- Summary Based Approval (Clinical Pharmacology)
- CMC Review Memo
- NDA Review Memo (Mid-Cycle) (PDF - 1.7 MB)
- Review Memo - PREA
Administrative Documents
- Officer/Employee List
- Filing Memo
- Categorical Exclusion under 21 CFR 25.31(c)
- Compliance Check
- Transmittal of Labels and Circulars (PDF - 67 KB)
- Record of Telephone Conversation with Fresenius Kabi - 12/17/2007 and 12/18/2007
- Memo - Blood Products Advisory Committee
Correspondence
- Acknowledgment Letter
- Telecon with Fresenius Kabi - 12/14/2007
- Telecon with Fresenius Kabi - 11/28/2007
- Telecon with Fresenius Kabi - 11/29/2007
- Telecon with Fresenius Kabi - 11/30/2007
- Telecon with Fresenius Kabi - 10/31/2007
- Memorandum Telecon with Fresenius Kabi - 6/18/2007
- 10/5/2007 Fax
- 9/13/2007 Fax
- 9/4/2007 Fax
- 8/3/2007 Fax
- 6/29/2007 Fax
- 6/29/2007 Fax