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Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-123 Treatment For Acne Vulgaris In Lotion Form.

ENPNewswire-August 8, 2019--Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-123 Treatment For Acne Vulgaris In Lotion Form

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Release date- 07082019 - Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-123 (tazarotene 0.045%) Lotion with a PDUFA action date of Dec. 22, 2019.

If approved, IDP-123 will be the first tazarotene acne treatment available in a lotion form.

'Millions of Americans are affected by acne and, for many of these patients, it can be difficult to find a treatment that works for them,' said Bill Humphries, president, Ortho Dermatologics. 'If approved, IDP-123 will offer physicians and their patients a lower concentration of tazarotene in a lotion formulation, helping to further expand upon our growing portfolio of acne treatments.'

The NDA submitted for IDP-123 includes data from two successfully completed Phase 3 randomized, placebo-controlled, double-blind clinical trials in 1,614 patients with moderate to severe acne. The primary efficacy endpoints included the absolute change in the mean noninflammatory and inflammatory lesion counts, the percentage of subjects who had a least a two-grade improvement from baseline to week 12 in the Evaluator Global Severity Score (EGSS) and who had 'clear' or 'almost clear' skin. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance (p

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Publication:ENP Newswire
Date:Aug 8, 2019
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