Pharmaceutical Processing - FDA extends marketing exclusivity for LEVAQUIN[R].(Industry News)
The FDA has granted LEVAQUIN[R] (levofloxacin) an additional six months of marketing exclusivity, known as “pediatric exclusivity.” The action attaches to the U.S. patent covering LEVAQUIN, extending exclusivity from December 2010 to June 2011. This decision was based on five, company-sponsored pediatric studies conducted at the request of the FDA.
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Pipeline
The studies included trials to determine the pharmacokinetic profile and the efficacy and safety of LEVAQUIN in children with community-acquired pneumonia (CAP) and recurrent and/or persistent acute otitis media. The …
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