FDA Approved Ruconest for Rare Genetic Disease

July 16, 2014 - The Food and Drug Administration (FDA) approved Ruconest manufactured by Salix Pharmaceuticals in North America.  Ruconest is used to treat symptoms of Hereditary Angioedema (HAE), a rare genetic disease.  Ruconest is the first recombinant C1-Esterase Inhibitor that will treat symptoms of HAE in both adults and children. 

After several years of development and testing, Salix plans to have Ruconest available to patients later this year.

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 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.

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