Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
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!)
..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…