December 19, 2019
December 19, 2019 – The U.S. FDA has approved Arazlo™ (tazarotene) lotion 0.045%, manufactured by Ortho Dermatologics. The product is indicated to provide topical treatment of acne vulgaris in patients who are at least nine years of age. Although the active ingredient has been FDA approved since 1997, Arazlo is the first tazarotene acne treatment available in a lotion form.
Acne is the most common skin condition seen in the United States, affecting up to 50 million people. It occurs when skin cells and oil become trapped in hair follicles. This can cause cysts, nodules, pimples, whiteheads, and blackheads. In some cases, the disease can be painful due to inflammatory lesions, and it can also cause scarring and significant emotional distress.
In a clinical study, Arazlo was found to have similar treatment success compared to Tazorac® (tazarotene – Allergan) Cream 0.1%, with fewer treatment-related adverse events. Only 2.9% of patients treated with Arazlo experienced an adverse event, compared to 5.6% with Tazorac. The lotion formulation may help patients tolerate Arazlo better than other tazarotene treatments due to the hydrating ingredients included in the formulation. Recommended dosing is a thin layer of Arazlo applied to affected areas once daily. Contact with the eyes, mouth, paranasal creases, and mucous membranes should be avoided.
Ortho Dermatologics plans to launch the product in the first half of 2020 but has not yet announced pricing plans.
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.