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# Primus Resubmits Generic Impoyz Petition
- URL: https://www.fdaweb.com/primus-resubmits-generic-impoyz-petition/
- Published: 2026-08-07T12:00:00.000Z
- Updated: 2026-09-14T13:44:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161596

Primus Pharmaceuticals has resubmitted a petition to FDA seeking specific actions on ANDAs for a generic form of the company’s Impoyz (clobetasol propionate) 0.025% topical cream, which is indicated for moderate to severe plaque psoriasis. The [petition](https://downloads.regulations.gov/FDA-2026-P-8647-0001/attachment%5F2.pdf?ref=fdaweb.com) notes the petition was originally submitted in 2020 by Encore Dermatology, from whom Primus acquired the Impoyz NDA in 2021.

Primus says Impoyz is a novel formulation of clobetasol propionate whose key characteristic is that it uses Transcutol (diethylene glycol monoethyl ether) without propylene glycol. It says the Glenmark ANDA showed its product contained more than 10% propylene glycol and never indicated it contained Transcutol. “Glenmark’s product raises questions of safety and efficacy that cannot be answered by relying on the clinical data for Impoyz,” Primus asserts.

The original petition raised the concerns about the Glenmark ANDA, and FDA denied the petition in 2020, saying it was not ready to make a formal determination on the ANDA. Primus says Encore resubmitted the petition to ensure that FDA considered the substantive issues it raised. Primus says FDA withdrew the petition without prejudice for resubmission on 3/3/2026 because the docket showed five years of inactivity.

According to Primus, FDA contacted Encore to ask if it wanted the petition to remain active in the change of NDA ownership but did not contact Primus. When Encore did not respond, the Primus petition says, FDA withdrew the petition and closed the docket.

“Primus is resubmitting the petition to ensure that FDA considers and addresses the substantive issues in conjunction with any action that FDA may take on the Glenmark application,” the document says.

Primus specifically asks that FDA:

- refuse to approve the Glenmark ANDA and any similarly formulated generic product because there is a “reasonable basis to conclude that Glenmark made formulation changes, including significant changes to the vehicle, that likely increase absorption and raise unanswered questions of safety and effectiveness”;
- require Glenmark and similarly situated generic applicants to submit their new formulations under a new drug application with adequate data demonstrating safety and effectiveness; and
- if FDA allows Glenmark and similarly situated generic applicants to proceed with an ANDA, require that they establish bioeq uivalence with a comparative clinical endpoint study, and support their ANDAs with **(1)** systemic exposure data, **(2)** HPA axis suppression data, and **(3)** local safety data to ensure that the proposed formulations have the same safety profile as Impoyz.