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FDA rejects Innocoll's application for postsurgical pain drug

Innocoll Holdings PLC received a rejection from the U.S. FDA relating to an application for XARACOLL, the company's product candidate to treat postsurgical pain.

In a preliminary review, the FDA indicated that the application submitted in October was not sufficiently complete to permit a substantive review. It also indicated, among other things, that the drug should be characterized as a drug/device combination, which would require Innocoll to submit additional information.

The company will request a Type A meeting with the FDA to respond to several issues believed to be addressable and seek clarification of what additional information, if any, will be required.