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FDA Accepts Resubmission of New Drug Application for Duobrii Lotion.

M2 PHARMA-August 30, 2018-FDA Accepts Resubmission of New Drug Application for Duobrii Lotion


- The US Food and Drug Administration has accepted the resubmitted New Drug Application for Duobrii (halobetasol propionate and tazarotene) (IDP-118) Lotion for the topical treatment of plaque psoriasis, prescription dermatology health care businesses Ortho Dermatologics said.

The FDA accepted the application as a Class 2 resubmission, with a PDUFA action date of February 15, 2019.

If approved, Duobrii will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.

About Ortho Dermatologics

Ortho Dermatologics, a Bausch Health 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, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses.

The Ortho Dermatologics portfolio includes several leading acne, anti-fungal and anti-infective products.

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Publication:M2 Pharma
Date:Aug 30, 2018
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