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Vaccines, Blood & Biologics
Alphanate
Proper Name: Antihemophilic Factor/von Willebrand Factor Complex (Human)
Tradename: Alphanate
Manufacturer: Grifols Biologicals Inc, License #1694
Indication:
- For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.
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Supporting Documents
- January 31, 2007 Approval Letter - Alphanate
- FDA Approves New Product to Treat Von Willebrand Disease
Press Release - February 2, 2007
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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