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BRIEF-Innocoll receives refusal to file letter from U.S. FDA for xaracoll new drug application
December 29, 2016 / 10:30 PM / 10 months ago

BRIEF-Innocoll receives refusal to file letter from U.S. FDA for xaracoll new drug application

Dec 29 (Reuters) - Innocoll Holdings Plc

* Innocoll Holdings - FDA indicated xaracoll should be characterized as drug/device combination, which would require co submit additional information

* Innocoll - company will request a type a meeting with FDA to seek clarification of what additional information, if any, will be required

* Innocoll holdings - FDA determined that application, which was submitted in october 2016, was not sufficiently complete to permit a substantive review

* Innocoll - co will request type a meeting with fda to respond to several issues believed to be addressable

* Innocoll receives refusal to file letter from U.S. FDA for xaracoll(bupivacaine HCL collagen-matrix implants) new drug application Source text for Eikon: Further company coverage:

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