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# Restrict ANDAs for Generic Zoryve: Arcutis
- URL: https://www.fdaweb.com/restrict-andas-for-generic-zoryve-arcutis/
- Published: 2023-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:17:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155931

Arcutis Biotherapeutics, Inc., is petitioning FDA not to approve any ANDA for a generic form of the company’s Zoryve (roflumilast) topical cream, 0.3%, that does not take steps dictated by Arcutis to demonstrate that the proposed generic is equivalent to Zoryve. The [petition](https://downloads.regulations.gov/FDA-2023-P-5364-0001/attachment%5F1.pdf?ref=fdaweb.com) says Zoryve is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients age six and older.

According to Arcutis, Zoryve cream contains roflumilast, a PDE-4 inhibitor, as the active ingredient, and has a novel topical formulation that includes two excipients the company believes are essential to its safety and effectiveness. The petition identifies them as Transcutol (diethylene glycol monoethyl ether), a solvent, and Crodafos CES (ceteareth-10 phosphate, cetearyl phosphate, cetostearyl alcohol), an emulsifier.

“Working together,” the petition says, “these ingredients can be expected to improve safety (primarily centrally mediated gastrointestinal adverse events and psychiatric adverse events) by reducing the rate of systemic absorption and peak-to-trough ratio, while also increasing local absorption and retention at the site of action, thereby potentially contributing to effectiveness.”

Arcutis calls on the agency to

- refuse to approve any ANDA for which Zoryve is the reference-listed drug unless the proposed generic product is Q1/Q2/Q3 the same as Zoryve cream, having the same inactive ingredients in the same concentrations and having the same physicochemical and structural properties and showing bioequivalence through appropriate *in vitro* studies, or the application contains information specified in the petition; and
- issue a product-specific bioequivalence guidance for roflumilast topical cream that recommends studies consistent with those requested in the petition.