Wilate Indications Expanded
August 13, 2015 – The U.S. Food and Drug Administration (FDA) approved new indication for Wilate, manufactured by Octapharma USA. Wilate is a human von Willebrand factor/coagulation factor V111 complex and this new approval is indicated to prevent excess bleeding during and after surgery for both children and adults who have von Willebrand disease. Wilate was originally approved in 2009 to treat bleeding for patients with severe von Willebrand disease and for patients with milder forms of the disease that are not managed by desmopressin. This drug is however not approved for the treatment of hemophilia.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.