FDA Rejects Innocoll’s Drug Application for the Postsurgical Pain Therapy Xaracoll

The FDA refused to accept Innocoll’s NDA for the implantable postsurgical pain reliever Xaracoll, following a preliminary review of the application that demonstrated several deficiencies.

In a refuse-to-file letter, the agency said the application — submitted in October — was not sufficiently complete to allow for a substantive review. The letter advises Innocoll to characterize Xaracoll as a drug-device combination product in a resubmission, which will require the inclusion of additional information in the NDA, the company said.

Innocoll intends to meet with the FDA to address the concerns raised in the letter and seek clarification on the supplement information required for a refiling.