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FDA issues Complete Response Letter for AbbVie's fast-acting neurotoxin TrenibotE, citing manufacturing issues only.

Market News
10 Jun 2026
GlobeNewsWire
View Source
Neutral
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AbbVie received a Complete Response Letter from the FDA regarding its application for TrenibotE, a fast-acting botulinum neurotoxin serotype E for treating moderate to severe glabellar lines. The FDA's concerns were limited to manufacturing process details, with no safety or efficacy issues raised, and no additional clinical trials requested. AbbVie plans to respond to the FDA's feedback in the coming months. TrenibotE is notable for its rapid onset and shorter duration compared to existing type A botulinum toxins, potentially appealing to patients seeking shorter-term effects.

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