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# No CDER Objection to Covis Materials for Makena Hearing
- URL: https://www.fdaweb.com/no-cder-objection-to-covis-materials-for-makena-hearing/
- Published: 2022-04-19T12:00:00.000Z
- Updated: 2026-09-14T17:41:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151630

CDER attorney **Christine Hunt** says the Center does not object to additional information Covis Pharma wants to present at an upcoming public [hearing](https://www.fdaweb.com/fda-grants-covis-hearing-request-on-makena/) on FDA’s proposal to withdraw approval for the company’s Makena (hydroxyprogesterone caproate injection). In a 4/18 [letter](https://downloads.regulations.gov/FDA-2020-N-2029-0211/attachment%5F1.pdf?ref=fdaweb.com) to hearing presiding officer **Celia Witten**, Hunt says that while CDER does not object to including the information, the Center “does not concede that Covis has appropriately characterized the conclusions to be drawn from the information it wishes to present. For example, with regard to Covis’s expressed intent to present at the hearing specific precedent for relying on real-world evidence (RWE), CDER’s position is that RWE would not be sufficient to verify clinical benefit for Makena given the failure of Trial 003 and the limitations of the RWE study Covis is proposing when applied to preterm birth. CDER will be prepared to justify this position at the hearing.”

Hunt also says CDER does not object to Covis presenting additional peer-reviewed articles addressing Makena’s safety or effectiveness and adds that CDER wants to be allowed to include a recent publication concerning the risk of certain cancers and in-utero exposure to hydroxyprogesterone caproate.