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# FDA Grants Covis Hearing Request on Makena
- URL: https://www.fdaweb.com/fda-grants-covis-hearing-request-on-makena/
- Published: 2021-08-19T12:00:00.000Z
- Updated: 2026-09-14T17:11:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149971

CDER has granted Covis Pharma Group’s request for a hearing on the Center’s 10/5/20 proposal to withdraw approval for Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly). An 8/18 CDER [response](https://downloads.regulations.gov/FDA-2020-N-2029-0072/attachment%5F1.pdf?ref=fdaweb.com) to the Covis request grants the hearing and addresses other procedural issues related to the proposal.

The letter says FDA acting commissioner **Janet Woodcock** has recused herself from the proceeding based on her previous involvement in CDER’s consideration of the matter and has delegated the commissioner’s role at the hearing to FDA chief scientist **Denise Hinton**. Hinton says she has named CBER deputy director **Celia Witten** as the presiding officer for the hearing.

In the letter, Hinton says Covis has justified its request for a hearing by providing specific challenges to the factual and scientific bases underlying CDER’s proposal and including or describing data and information in support of its challenges. She directs CDER to review Covis’ request for disclosure of documents and respond within 30 days to the company’s position that FDA should disclose the “full files regarding its decision to withdraw approval for Makena” and especially categories of documents sought by Covis.