Xuriden Approval for Treating Hereditary Orotic Aciduria
September 14, 2015 – The U.S. Food and Drug Administration (FDA) granted the first ever approval to Wellstat Therapeutics’ Xuriden (uridine triacetate) oral granules for the treatment of hereditary orotic aciduria (HOA). HOA is a rare metabolic disorder that has been reported in approximately 20 patients worldwide. People with this disorder may have blood abnormalities, urinary tract obstruction and developmental delays. Xuriden is a prodrug of uridine and provides four to seven times more uridine than oral uridine administration. Designated as an orphan drug, and granted priority review by the FDA; Xuriden was also granted a rare pediatric disease priority review voucher. Xuriden is approved as oral granules that can be mixed with food or in milk or infant formula. Xuriden should be administered daily. It will be available as orange-flavored granules in single-use 22g packets on 30-count cartons. The expected launch date for Xuriden is early 2016.
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.