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| |  FDA Grants Cipro (Ciprofloxacin) Additional Six Months Marketing Exclusivity WEST HAVEN, CT -- December 19, 2003 -- Bayer Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (FDA) has granted it an additional six months of market exclusivity for its fluoroquinolone antibiotic Cipro® (ciprofloxacin) for having conducted pediatric clinical trials. With this additional six months of exclusivity, no unauthorized generic versions of ciprofloxacin will be approved to enter the market prior to June 9, 2004. According to the terms of the Best Pharmaceuticals for Children Act of 2002, the FDA may grant a drug additional marketing exclusivity if a company conducts clinical studies in certain pediatric populations at the written request of the FDA. The granting of additional marketing exclusivity means a company has successfully met the criteria established by the FDA for conducting the clinical trials. This provision is designed to encourage further investigation into the unmet medical needs of the pediatric population. "As a leader in anti-infective therapies, it is a priority for Bayer to further the understanding about the use of quinolone antibiotics in the pediatric population," said Colin J. Foster, President, Bayer Pharmaceuticals Corporation. "We are pleased to be working with the FDA to provide the medical community with all the scientific data gathered from our studies." Cipro® received pediatric marketing exclusivity upon the FDA determining that Bayer had successfully fulfilled the agency's written request to perform clinical studies evaluating the safety of ciprofloxacin in children. The FDA originally approved Cipro in 1987 for a broad range of infections, including lower respiratory tract, urinary tract, skin and skin structure, bone and joint infections and infectious diarrhea. In December 2002, the FDA approved Cipro® XR (ciprofloxacin extended-release tablets) as a once-daily, three-day treatment for uncomplicated urinary tract infections in adults at a dose of 500mg. The FDA also approved a 1000mg dose of Cipro XR for the treatment of complicated UTIs in adults in August 2003. Cipro XR 500mg and 1000mg have not been involved in pediatric clinical trials. You can view full prescribing information for Cipro at http://www.ciprousa.com You can view full prescribing information for Cipro XR at http://www.ciproxr.com.
SOURCE: GCI Group
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