Medytox Next-Generation Toxin, FDA Approval Review Rejected

Medytox's application for approval of its botulinum toxin formulation submitted to the U.S. Food and Drug Administration (FDA) has been rejected.

On the 26th, Medytox announced, "On the 24th, the FDA rejected the approval review for MT10109L, a non-animal-derived liquid botulinum toxin formulation, which we had applied for."

In December of last year, Medytox applied for FDA approval of MT10109L with indications for improving glabellar lines and crow's feet. MT10109L is a botulinum toxin formulation that does not use animal-derived ingredients or albumin extracted from human serum, thereby fundamentally eliminating the risk of animal virus infection. It was expected to become the first liquid toxin to enter the U.S. market upon approval. Unlike the conventional freeze-dried powder type that requires dilution with saline, the liquid type does not require a dilution process, eliminating infection risks during dilution and allowing medical professionals to conveniently perform precise dosing.

However, this rejection does not mean that the drug approval itself was denied. FDA drug approvals are not accepted immediately upon application; there is a separate acceptance period for receiving applications. The FDA conducts a preliminary review of the application for about two months to decide whether to ▲accept the approval review ▲potentially reject ▲reject the approval review. In other words, the application was not accepted for review, but no final decision has been made regarding the approval itself.

The company stated, "We were notified by the FDA that the approval review was rejected due to 'insufficient specific validation test reports' in the submitted materials," and added, "We have immediately begun supplementing the relevant materials and plan to resubmit the application promptly through consultations with the FDA."