Ortho Dermatologics announces U.S. FDA filing acceptance for IDP-121 acne treatment in lotion form.
Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (Altreno1) 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.
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 disease.2
Ortho Dermatologics is a prescription dermatology businesses focused on helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis, and other dermatoses. The Ortho Dermatologics portfolio includes several acne, anti-fungal, and anti-infective products.
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures, and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology, and branded generics.
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References:
1 Provisional name
2 White GM. Recent findings in the epidemiologic evidence, classification, and subtypes of acne vulgaris. J Am Acad Dermatol. 2004;39:S34-37
(Source: Valeant Pharmaceuticals International, Inc.)
Filed Under: Drug Discovery
