BioCentury
ARTICLE | Regulation

Antibiotic resistance

October 30, 2006 8:00 AM UTC

FDA's rejection of Replidyne Inc.'s faropenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections. But the absence of agency guidance forces developers to guess what protocols might work, a burden industry may not choose to take on despite the fact the U.S. spends $8.5 billion on oral antibiotics in the U.S. annually.

The non-approvable letter, announced last week by RDYN (Louisville, Colo.) and partner Forest Laboratories Inc. (FRX, New York, N.Y.), rejected all four indications sought in the NDA: acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB), uncomplicated skin and skin structure infections (SSSIs) and community-acquired pneumonia (CAP). ...