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The U.S. Food and Drug Administration (FDA) announced Tuesday that AbbVie (NYSE:ABBV) is collaborating with the agency in an investigation into counterfeit versions of the company’s anti-wrinkle injection, Botox.
The probe came after several states reported counterfeit Botox versions, including cases of hospitalizations linked to the products in question, the agency said.
“FDA’s investigation is ongoing, and the agency is currently working with AbbVie (the Botox manufacturer) to identify, investigate and remove suspected counterfeit Botox products found in the U.S.,” the regulator said in a statement.
Noting reports of adverse reactions linked to counterfeit Botox, including shortness of breath and difficulty swallowing, the FDA said that healthcare professionals and consumers should report those events to a federal database.
A form of purified botulinum toxin, Botox generated $5.7B in net revenue for AbbVie (ABBV) in 2023 with ~6% YoY growth. Other makers of botulinum-toxin-based cosmetic products include Revance Therapeutics (RVNC) and Evolus (EOLS).
AbbVie (ABBV) added Botox to its product portfolio with its $63B acquisition of Allergan in 2020.