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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  01/31/2020
Trade Name:  PALFORZIA
Generic Name or Proper Name (*):  Peanut (Arachis hypogaea) Allergen Powder-dnfp*
Indications Studied:  Mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years and older
Label Changes Summary:  See Package Insert for new information on biologics
Sponsor:  Aimmune Therapeutics, Inc.
Therapeutic Category:  Allergenic extract