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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2007 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.


Tradename/
Established Name
Indication for Use NDA Number Applicant Approval Date
Voluven®
6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (Voluven 500 mL freeflex flexible plastic intravenous solution container)
Treatment and prophylaxis of hypovolemia BN070012 Fresenius Kabi
Deutschland GmbH
Else-Kroner-Strasse 1
61352 Bad Homburg v.d.H., Germany
12/27/2007