> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Covis Seeks FDA Actions on Eugia Pharma ANDA
- URL: https://www.fdaweb.com/covis-seeks-fda-actions-on-eugia-pharma-anda/
- Published: 2021-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:07:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149744

Covis Pharma is asking FDA to take several administrative actions on a Eugia Pharma NDA for a generic version of Makena Autoinjector. A 7/19 [petition](https://downloads.regulations.gov/FDA-2021-P-0767-0001/attachment%5F1.pdf?ref=fdaweb.com) asks that the agency **(1)** review the basis for submission of the ANDA; **(2)** determine that the ANDA should have been filed as a 505(b)(2) NDA; **(3)** conclude that FDA should have refused to receive the ANDA; and **(4)** require Eugia to refile the application as a 505(b)(2) NDA.

Covis says it acquired sponsorship of the Makena NDA 3/2021 when its affiliate acquired AMAG Pharmaceuticals. It describes Makena (hydroxyprogesterone caproate) as a progestin drug indicated to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. It was designated as an orphan drug and the original sponsor received accelerated approval in 2011.

The petition says Covis has had concerns about any sponsor attempting to replicate the Makena Autoinjector drug-device combination product that was approved in 2018 under the same NDA. It says it learned from Eugia responses in patent litigation that its product may not be an autoinjector, that the administration of the drug products might differ, and that the indications for use may not be identical. “If so,” the petition says, “then the Makena Autoinjector and Eugia’s proposed generic product are, in fact, two different products. In such a case, Eugia should have filed a 505(b)(2) NDA and not an ANDA, and FDA should have refused to receive the ANDA.”