FDA approves generic version of ciprofloxacin for UTIs

May 22, 2005

Depomed, Inc. has received approval from the FDA for a once-daily formulation of ciprofloxacin hydrochloride (Proquin XR) for the treatment of uncomplicated urinary tract infections. It is the first version of ciprofloxacin with nausea and diarrhea listed as "uncommon" adverse events, rather than "common" adverse events, according to the company.

Depomed, Inc. has received approval from the FDA for a once-daily formulation of ciprofloxacin hydrochloride (Proquin XR) for the treatment of uncomplicated urinary tract infections. It is the first version of ciprofloxacin with nausea and diarrhea listed as "uncommon" adverse events, rather than "common" adverse events, according to the company.

The new formulation is designed to gradually release the drug over 6 hours, allowing patients to potentially avoid side effects that other ciprofloxacin formulations can cause. In a randomized, double-blind, phase III clinical trial of 1,037 patients with uncomplicated UTIs, the drug eradicated the bacteria most commonly responsible for causing UTIs comparably to twice-daily Cipro.