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FDA requests manufacturing info for AbbVie's trenibotulinumtoxinE, no new clinical trials needed

Market News
23 Apr 2026
PRNewsWire
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AbbVie received a Complete Response Letter from the FDA concerning its biologics license application for trenibotulinumtoxinE (TrenibotE), a novel botulinum toxin with rapid onset and short duration. The FDA's request focuses solely on additional manufacturing process details, with no safety or efficacy concerns raised and no new clinical trials required. AbbVie plans to address the FDA's comments promptly and expects to submit a thorough response soon. Regulatory reviews in other countries are ongoing as expected.

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