BRIEF—Acne lotion filing accepted by FDA

12 January 2018

Ortho Dermatologics, a division of Canadian drugmaker Valeant Pharmaceuticals International, has announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion with a PDUFA action date of August 27 this year.

If approved, the treatment, branded as Altreno, will be the first tretinoin product in lotion form rather than a gel or cream. It is being developed for patients with acne, the most common skin disease, affecting around 50 millions Americans.

Joseph Papa, chairman and chief executive of Valeant, said: “More than four 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.”



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