Sunday, 20 January 2019

USFDA accepts NDA of Ortho Dermatologics for acne treatment

15 January 2018 | News

Ortho Dermatologics Announces U.S. FDA Filing Acceptance for IDP-121 Acne Treatment in Lotion Form

Ortho Dermatologics, a Valeant Pharmaceuticals International, Inc. company, is one of the largest prescription dermatology businesses in the world dedicated to helping patients in the treatment of a range of therapeutic areas

The company announced that the U.S. Food and Drug Administration (FDA) have accepted the New Drug Application (NDA) for IDP-121 (tretinoin 0.05%) lotion (ALTRENO™1) 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.

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.

As per the company, More than 4 million patients make appointments with dermatologists each year for acne. After approval, ALTRENO will be great resource for the treatment of all dermatological conditions.


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