Cardiothoracic
Innocoll Announces Outcome of FDA Meeting to Commence Phase 3 Development of its CollaRx GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections
Published in Medical Verdicts and Law Weekly, May 10th, 2007
Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that following a pre-Investigational New Drug (IND) application meeting, the U.S. Food and Drug Administration (FDA) has accepted Innocoll's proposal to commence the development of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT in the U.S. at phase 3. In consideration of the positive outcome to this meeting, Innocoll plans to file an IND within the second quarter 2007 for the target indication of prevention of surgical site infection in patients undergoing open chest or abdominal surgery as an adjunct to standard infection prophylaxis.
Innocoll has appointed Duke University's Duke Clinical Research...
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