Bayer HealthCare AG announced that the US Food and Drug Administration (FDA) has granted it an additional six months of market exclusivity for its fluoroquinolone antibiotic Cipro (ciprofloxacin) for having conducted paediatric 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 paediatric 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 paediatric 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 paediatric 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 paediatric 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.
Bayer HealthCare, a subgroup of Bayer AG with annual sales amounting to some 10 billion euro, is one of the world's leading, innovative companies in the health care and medical products industry. More than 34,000 employees work for Bayer HealthCare worldwide. Bayer HealthCare combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals divisions.