Trends and Considerations in Global Infectious Disease Drug Dev | Page 6

During the 1990s, the development efforts and

Figure 5. Challenges

to Successful Development: FDA Guidance

safety focus was on fluoroquinolones. However,
temafloxacin, approved in 1992, and high-profile
drugs such as grepafloxacin and the oral
formulation of trovafloxacin, were subsequently
withdrawn from the market because of serious
safety concerns.
The approval of Ketek® (telithromycin) in 2003
and its subsequent withdrawal for safety and
absence of a treatment benefit using a justified
non-inferiority margin set the stage for the rejections
of other antimicrobial NDAs for which there were no identified safety issues.

Challenges for Successful Antimicrobial Drug Development Since 2000 »
FDA Guidance
Since 2005, the FDA has issued numerous new guidelines for antimicrobial drug clinical trials. For example, in 2008, the FDA issued a guidance
for acute bacterial exacerbation of chronic bronchitis, addressing superiority study design, population definition, and the inability to conduct
a placebo-controlled study. Another new guideline published in 2012 was for complicated urinary tract infection, addressing