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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
 
PREA(P):  P
 
Sponsor:  Aimmune Therapeutics, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Allergenic extract
 
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