EuBiologics said it has voluntarily withdrawn its application for a domestic item license for Eubitox 100 units, its botulinum toxin (BTX) treatment because it missed the timing for supplementary data submission to the regulator.
The company applied to the Ministry of Food and Drug Safety for approval for Eubitox to improve moderate and severe glabellar lines, after confirming similar efficacy and safety between Eubitox and the control group Allergan's Botox in a local phase 3 clinical trial.
However, during the MFDS review process, the company was asked to supplement data related to the manufacturing of the original solution and finished product of Eubitox.
"While preparing the data of the manufacturing company, the deadline for supplementation set on June 30 has arrived and the company decided to withdraw the application voluntarily," EuBiologics said in a public filing on Wendesday. "As a result, we will first voluntarily withdraw and reapply as soon as we secure the data of the contract manufacturer of the original solution and finished product."
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