FDA Approves Once-Daily Cipro (Ciprofloxacin) XR For Uncomplicated Urinary Tract Infections

Uncomplicated UTIs Result in More Than 8 Million Doctor Visits Annually; Extended Release Formulation Provides Once-a-Day Dosing For Patients

Bayer Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Cipro® XR (ciprofloxacin* extended-release tablets), a new formulation of ciprofloxacin, given once-a-day over three days, for the treatment of uncomplicated urinary tract infections (UTIs) due to susceptible strains of indicated organisms.

 Cipro XR will be marketed for use at a dosage strength of 500 mg. Cipro XR was developed using a bilayer matrix of the active ingredient ciprofloxacin, and enables two different release mechanisms. The first is a rapid release of ciprofloxacin, which distributes to the serum and tissues within hours. This is followed by a second extended release of the active ingredient to allow sustained levels over 24 hours.

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