TaiRx‘s injectable product, Zelnite®, has been approved by TFDA to add high dosage and change drug labeling


In 2018, TaiRx received approval from the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare for a new drug license, Zelnite® for injection packed in 2-mL ampoules, which is used to treat selenium deficiency or prevent selenium deficiency in patients receiving parenteral nutrition. The approved daily dose for adults is 100 to 200 mcg of selenium. In order to expand the applicability of the product, TaiRx obtained approval from the TFDA on May 9, 2024 for a new dosage of Zelnite® based on the Phase III clinical trial data of high-dose selenium (formerly Rexis®, packed in 10 mL/vial) in the adjuvant treatment of sepsis, along with relevant clinical references. The daily dose for treating selenium deficiency can be increased up to 500 mcg of selenium to accommodate medical needs.