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# Complete Response on Innocoll Combo Pain Product
- URL: https://www.fdaweb.com/complete-response-on-innocoll-combo-pain-product/
- Published: 2017-01-04T12:00:00.000Z
- Updated: 2026-09-14T21:57:59.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137628

FDA has issued Innocoll a refuse-to-file letter for Xaracoll, the company’s combination product candidate for treating postsurgical pain, because the submission was not sufficiently complete to permit a substantive review. In the letter, FDA indicated, among other things, that Xaracoll should be characterized as a drug/device combination, which would require it to submit additional information. The company says it will request a Type A meeting to respond to several issues believed to be addressable and seek clarification of what additional information will be required.

Xaracoll is a surgically implantable and bioresorbable bupivacaine-collagen matrix that uses the company’s CollaRx proprietary collagen-based delivery technology and is being developed to provide sustained postsurgical pain relief directly into the surgical site, according to Innocoll. The product is also designed to reduce the need for systemic opioids and their associated risks.