Home » FDA » Page 14

Tag Archives: FDA

Dalbavancin Approval Issues: A Case of Much Ado About Nothing

Posted on by — 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→

Avycaz Approval and Labeling Restrictions

Posted on by — No Comments ↓

On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’.  As a QIDP drug, Avycaz received priority review.  Its label states that it is indicated for infections caused by pathogens proven or ‘suspected to Continue reading Avycaz Approval and Labeling Restrictions→

Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

Posted on by — No Comments ↓

It is no secret that most existing antibiotic guidelines are not getting much use these days.  The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.  Yes, the occasional HABP/VABP trial is being undertaken by the intrepid but no company has taken Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)→