FDA Approves Tazarotene Lotion, 0.045%, for Acne Vulgaris

December 20th 2019

Tazarotene is the first acne treatment to be available in a lotion form, showing strong efficacy with favorable tolerability, according to the company.

The FDA has approved the new drug application for Ortho Dermatologics’ tazarotene (Arazlo) lotion, 0.045%, for the topical treatment of acne vulgaris in patients age 9 years and older. Tazarotene is the first acne treatment to be available in a lotion form, showing strong efficacy with favorable tolerability, according to the company.

The approval comes from results of 2 different phase 3 randomized, double-blind clinical trials that included 1614 patients with moderate to severe acne. All primary endpoints were met with statistical significance, showing tazarotene lotion to be generally well-tolerated in the clinical study population.

In addition, a phase 2 head-to-head study between 2 tazarotene creams, 0.1% and 0.045%, showed the latter had similar treatment success rates, and similar reductions in both inflammatory and noninflammatory lesions over 12 weeks.

Common adverse effects of tazarotene lotion, 0.045%, include skin dryness, pain, redness, excessive flaking, or peeling.

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