The FDA has accepted Ortho Dermatologics' New Drug Application for IDP-121 (tretinoin 0.05%) lotion (Altreno) with a PDUFA action date of Aug. 27, 2018. If approved, Altreno will be the first tretinoin product in lotion form rather than a gel or cream.
"More than 4 million patients make appointments with dermatologists each year for acne. It is our goal to be the go-to resource for doctors and patients for all dermatological conditions, and if approved, ALTRENO will be a valuable addition to the Ortho Dermatologics portfolio," said Joseph C. Papa, chairman and CEO, Valeant. Ortho Dermatologics is a division of Valeant Pharmaceuticals International, Inc.