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# Innocoll NDA Resubmitted for Pain Product
- URL: https://www.fdaweb.com/innocoll-nda-resubmitted-for-pain-product/
- Published: 2020-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:09:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146424

FDA has accepted an Innocoll Holdings NDA resubmission for Xaracoll (bupivacaine hydrochloride collagen-matrix implants), an investigational agent for managing postsurgical pain after open inguinal hernia surgery. The agency set a user fee goal date of 8/26.

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.

In 2016, FDA issued Innocoll a refuse-to-file letter for Xaracoll 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. 

After a Type A meeting with FDA, the agency specified the following requirements for an acceptable NDA: an additional short-term pharmacokinetic study, several short-term nonclinical toxicology and biocompatibility studies, additional manufacturing information to address the new combination product designation and other chemistry, manufacturing and control information, according to the company.