Because Bayer conducted pediatric clinical trials on Cipro at the FDA's request, the government agency approved the additional six-month window of exclusivity. No unauthorized generic versions of Cipro (ciprofloxacin) can be approved to enter the market prior to June 9, 2004.
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. The drug came to prominence two years ago as an antidote to anthrax, at the height of the terrorism scare in the country following the Sept. 11 attacks.
There is no consumer advertising for the product. The extra six months will allow Bayer to switch consumers to Cipro XR, an extended-release version of the antibiotic. Omnicom Group's Lyons Lavey Nickel Swift, New York, handles the account for Cipro XR, which was just approved by the FDA in October.
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 pediatric groups at the written request of the FDA. This provision is designed to encourage further investigation into the unmet medical needs of children.