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Tag Archives: FIAU

Dalbavancin Approval Issues: A Case of Much Ado About Nothing

Posted on September 7, 2015 by Harald — No Comments ↓

Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004.  Pfizer acquired dalbavancin as a “Phase 3 completed” drug ready for world-wide marketing on June 15, 2005. The Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing→

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Posted in QIDP Antibiotics, The Viewpoint | Tagged AIDAC, Anti-Infective Drug Advisory Committee, antibiotic blog, approvable letter, Cubicin, dalbavancin, Dalvance, daptomycin, Dr. Kelly, EMA, ethylene glycol, FDA, FIAU, Ketek, Lilly, non-inferiority, Omniflox, Pfizer, QIDP, Snodgrass, SPA, Special Protocol Assesssment, TeGenero, telithromycin, temafloxacin, TGN-1412, thalidomide, Vicuron | Leave a reply

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