The U.S. Food and Drug Administration has accepted the marketing application for an acne treatment developed by Bausch Health Cos. Inc. and its dermatology business Ortho Dermatologics Inc., called IDP-123.
IDP-123, or tazarotene 0.045%, will be the first tazarotene acne treatment available in a lotion form if it gains approval from the U.S. regulator.
Acne occurs when hair follicles become plugged with oil and skin cells, leading to whiteheads, blackheads or pimples on the face, forehead, chest, upper back and shoulders. The skin condition — one of the most common in the U.S. — affects up to 50 million Americans, according to an Aug. 7 news release.
The new drug application for IDP-123 is based on data from two phase 3 studies, which showed that treatment with IDP-123 significantly improved the severity of noninflammatory and inflammatory lesions compared to placebo.