1. Date of Event: 2013/03/04
2. Content of Annoucement:
(1) Microbio received the approval of new drug application from Taiwanese Food and Drug Administration (TFDA) for its Herbiron Oral Solution, which is indicated for the relief of iron deficiency anemia and menstrual symptoms.
(2) Herbiron is a proprietary drug developed by the Microbio in accordance to international drug development regulations, with comprehensive analysis in preclinical toxicology and pharmacology, and thorough CMC and manufacture standards. Microbio has filed US and World patent protection of Herbiron. The phase III clinical data shows therapeutic efficacy of “Herbiron” significantly elevate serum hemoglobin (*p<0.0001), red blood cell volume, and serum ferritin level.
2. Additional Information:
Herbiron is the second self-developed new drug of Microbio to receive approval from the TFDA.