Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
07/15/2015
Trade Name:
Epiduo Forte
Generic Name or Proper Name (*):
adapalene and benzoyl peroxide
Indications Studied:
Treatment of acne vulgaris in patients 12 years and older
Label Changes Summary:
*New higher strength combination formulation approved in adults and patients 12 years and older. *Safety and effectiveness in pediatric patients under the age of 12 have not been established. *Information on PK, adverse reactions, and clinical trial in adults and pediatric patients. *New dosage form.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Galderma
NNPS:
FALSE
Therapeutic Category:
Antiacne, topical
-
-