Plus   Neg

Valeant Pharma's Ortho Dermatologics: FDA Accepts NDA For IDP-121 Lotion

Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO), announced Friday that the U.S. Food and Drug Administration has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (ALTRENO1) with a PDUFA action date of Aug. 27, 2018 for acne treatment.

If approved, ALTRENO will be the first tretinoin product in lotion form rather than a gel or cream.

Acne, also known as acne vulgaris, is the most common skin disease in the United States, and as many as 50 million people in the United States may have the disease2

Joseph Papa, chairman and CEO, Valeant, said, "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."

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT