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FDA Grants Cipro(R) Additional Six Months Marketing Exclusivity.

Publication: PR Newswire
Publication Date: 18-DEC-03 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
WEST HAVEN, Conn., Dec. 18 /PRNewswire/ -- Bayer Pharmaceuticals Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted it an additional six months of market exclusivity for its fluoroquinolone antibiotic Cipro(R) (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...

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