Hugel smooths out wrin­kles with FDA, wins ap­proval for Botox com­peti­tor

There’s a new Botox com­peti­tor in town: Hugel Aes­thet­ics won ap­proval for Lety­bo, its neu­ro­tox­in in­jec­tion for mod­er­ate to se­vere frown lines.

De­spite its avail­abil­i­ty in Eu­rope and Cana­da, Lety­bo faced a cou­ple wrin­kles in its path to the US mar­ket. The drug was re­ject­ed in March 2022 over is­sues “pri­mar­i­ly as­so­ci­at­ed with chem­istry, man­u­fac­tur­ing, con­trols (CMC), and gen­er­al up­dates,” the com­pa­ny said. It was turned down again the fol­low­ing year.

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