> ## 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.

# FDA Says Merck’s Cubicin Not Complying with PREA Study
- URL: https://www.fdaweb.com/fda-says-mercks-cubicin-not-complying-with-prea-study/
- Published: 2016-04-28T12:00:00.000Z
- Updated: 2026-09-14T20:58:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135522

FDA says that Merck has failed to meet its Pediatric Research Equity Act (PREA) study requirement for Cubicin (daptomycin for injection) that was due 8/31/15\. In a 3/3 [letter](http://www.fda.giv/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM497923.pdf?ref=fdaweb.com) to the company, the agency notes that Merck had requested a deferral extension and that FDA had determined that the request does not qualify for an extension.

In its [response](http://www.fda.giv/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM497924.pdf?ref=fdaweb.com), Merck says that it remains committed to meeting its post-marketing study requirements. It offers a proposal that was redacted before the letter was posted by FDA.