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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

• 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

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.