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CANCELLED: Allergenic Products Advisory Committee

On May 15, 2020, the Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A for treatment of patients 4 through 11 years old with a confirmed diagnosis of peanut allergy.

UPDATED INFORMATION (as of 3/17/2020): The Allergenic Products Advisory Committee meeting scheduled for May 15, 2020, to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A has been cancelled to allow time for the FDA to review outstanding issues. The Agency intends to continue evaluating the product and will schedule an Advisory Committee meeting in the future, as needed.