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Xuriden Approval History

  • FDA approved: Yes (First approved September 4th, 2015)
  • Brand name: Xuriden
  • Generic name: uridine triacetate
  • Dosage form: Oral Granules
  • Company: Wellstat Therapeutics Corporation
  • Treatment for: Hereditary Orotic Aciduria

Xuriden (uridine triacetate) is an orally administered pyrimidine analog uridine replacement product for the treatment of patients with hereditary orotic aciduria.

Hereditary orotic aciduria is a rare autosomal recessive disorder caused by a defective or deficient enzyme resulting in the body being unable to normally synthesize uridine, a necessary component of ribonucleic acid (RNA). The condition is characterized by retarded growth, anemia and excessive excretion of orotic acid in the urine. Xuriden works as a uridine replacement product. It is supplied in the form oral granules which are administered once daily, mixed with soft food, or in milk or infant formula. Xuriden was well tolerated in clinical trials and no side effects were observed in patients who received treatment for up to nine months.

Development History and FDA Approval Process for Xuriden

Sep  4, 2015Approval FDA Approves Xuriden (uridine triacetate) to Treat Hereditary Orotic Aciduria

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