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:
08/22/2018
Trade Name:
Altreno lotion
Generic Name or Proper Name (*):
tretinoin
Indications Studied:
Topical treatment of acne vulgaris
Label Changes Summary:
*Safety and effectiveness have been established in pediatric patients age 9 years to less than 17 years based on evidence from two multicenter, randomized, double-blind, 12-week trials and an open-label pharmacokinetic study. A total of 318 pediatric subjects aged 9 to less than 17 years received Altreno in the clinical studies. *Safety and effectiveness in pediatric patients below the age of 9 years have not been established. *Information clinical trials, PK parameters, and adverse reactions. *New dosage form.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Dow Pharmaceutical Sciences, Inc.
NNPS:
FALSE
Therapeutic Category:
Antiacne, topical
-
-