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Approval of First Generic for Atralin® (tretinoin) Gel, 0.05%

Spear Dermatology Products, Inc. announces the U.S. launch of Tretinoin Gel, USP 0.05%, which is the first generic version of Valeant’s Atralin® (tretinoin) Gel, 0.05%. Spear Pharmaceuticals received the approval from the U.S. Food and Drug Administration (FDA) on August 13, 2015. This is the 11th first generic approval for Spear Pharmaceuticals, all of which were topical Dermatology products. Spear Dermatology Products, Inc., the sales and marketing arm of Spear Pharmaceuticals, Inc., will sell the product.

Tretinoin Gel 0.05% is a retinoid indicated for the topical treatment of acne vulgaris. It contains micronized particles of tretinoin in a moisturizing hydrogel vehicle, thus providing excellent tolerability without compromising efficacy. The Tretinoin Gel 0.05% formulation contains excipients commonly found in moisturizer products, such as sodium hyaluronate, glycerin, and soluble collagen, so it is less drying than other Tretinoin products.

Tretinoin Gel, USP 0.05% is proven to be clinically safe and effective. Tretinoin Gel 0.05% demonstrated clinical bioequivalence to Atralin Gel 0.05% and statistical superiority to Gel Vehicle, as demonstrated by the percent change from baseline in inflammatory and non-inflammatory lesions at Week 12.(1)

Following the new Generic Drug User Fee Act (GDUFA) goals for formal drug application review, Tretinoin Gel, USP 0.05% was the first fiscal year 2015 (FY 2015) application to be approved under these auspices. In fact, the approval came five months early, compared to the GDUFA’s proposed 15-month goal.(2) More specifically, for FY 2015 (starting October 1, 2014), GDUFA set a goal of 60% of ANDAs that are submitted during this year have to be acted upon within 15 months.

According to a recent Pink Sheet Article, “The agency said that the early approval was a testament to the potential for the new generic drug user fee program and the reward for submitting a quality application.”2 The Agency said in an email to Pink Sheet, “This approval can serve as an example of what can be achieved through good communication and integration of effort on an application that is complete and free of issues requiring multiple information requests or complete responses.”(2)

Full prescribing information is available at

Safety Information Product in some patients may cause redness, itching, burning, stinging and peeling. If the degree of irritation warrants, patients should be advised to use less medication and decrease the frequency of application. If still significant, discontinue.

1. Data on file, Spear Pharmaceuticals. 2. Gingery, Derrick. FDA Approves Its First ‘Clocked’ ANDA. The Pink Sheet Daily. Retrieved August 19, 2015.


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