Progress Report: New Antibacterials In the Fight against MDR Bacteria

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria

Food for Thought, Sprinkled With Small Amounts of Antibiotic Residues

80% of antibiotics worldwide are used in veterinary medicine. With only a minor fraction metabolized to inactive compounds, there are plenty of antibiotics excreted by farm animals in unchanged active form. These antibiotic residues are found in manure, in the Continue reading Food for Thought, Sprinkled With Small Amounts of Antibiotic Residues

Avycaz Approval and Labeling Restrictions

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 Continue reading Avycaz Approval and Labeling Restrictions

Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

When older drugs get reintroduced into clinical practice because pathogens have developed resistance to newer agents, it comes at the price of uncertainty. Often, older drugs were approved based on rather limited data, often considered incomplete by today’s standards.  Take colistin Continue reading Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

No Such Thing as a Free Ride…

..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 Continue reading No Such Thing as a Free Ride…