FDA Clears Trovafloxacin With Ultra-Broad Indications

Pfizer's once-daily quinolone antibiotic Trovan (trovafloxacin) has beenapproved for marketing in the USA with the broadest number of indications ever awarded at initial registration. This is the first approval of the product, which is scheduled to reach the market in February.

Pfizer will emphasize this ultra-broad utility in its marketing efforts for the antibiotic. Trovafloxacin is available in both oral and intravenous (altrofloxacin) forms and is approved for 14 indications. It is the first antibiotic ever to be licensed for oral prophylactic use during surgery, and promotional activities will concentrate on surgical and respiratory indications for the antibiotic.

Trovafloxacin's other indications are acute bacterial exacerbations of chronic bronchitis, acute sinusitis, community-acquired pneumonia, hospital-acquired pneumonia, complicated intra-abdominal infections, gynecologic and pelvic infections, uncomplicated urinary tract infections, chronic bacterial prostatitis, pelvic inflammatory disease, chlamydial cervicitis, gonorrhea, uncomplicated skin and skin structure infections.