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Treatment of uncomplicated urinary tract infections
registration for Bayer's Cipro(R) XR antibiotic
Leverkusen (ots) - The U.S. Food and Drug Administration (FDA) has approved Bayer's antibiotic product Cipro(R) XR (Ciprofloxacin Extended-Release Tablets). This new formulation, given once a day over three days, is designed to treat uncomplicated urinary tract infections (UTIs). Cipro(R) XR will be marketed in a dosage strength of 500 mg, and Bayer will begin shipping the product to U.S. pharmacies on January 2, 2003.
Cipro(R) XR releases the active ingredient from two layers. The first releases ciprofloxacin into the blood within hours. This is followed by a second extended release of the active ingredient to allow sustained levels over 24 hours.
A study with 891 women showed that once-daily administration of Cipro(R) XR was as effective as conventional ciprofloxacin administered twice a day. A clinical cure was achieved in 95 percent (Cipro(R) XR once daily) versus 93 percent (ciprofloxacin twice daily).
Dr. Wolfgang Plischke, President of the Pharmaceuticals Division at Bayer HealthCare, commented on the registration: "We can now offer patients a more convenient medication for the targeted therapy of uncomplicated urinary tract infections."
According to the National Institutes of Health in the USA, urinary tract infections are the second most common type of infection, accounting for more than eight million doctor visits annually in the USA. Women are especially prone to UTIs.
Bayer submitted an application to the FDA in October 2002 to market Cipro(R) XR tablets in a 1000 mg dosage strength for once-a-day therapy of complicated urinary tract infections.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F).The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
ots Originaltext: Bayer AG
Dr. Michael Diehl