The FDA has granted LEVAQUIN® (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.
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 studies were conducted in close collaboration with leaders in the pediatric and infectious disease communities and in consultation with the FDA. LEVAQUIN is not indicated for use in children and adolescents (under 18 years of age).
Since its U.S. introduction in 1996, LEVAQUIN has gained widespread use in the treatment of adults for a variety of bacterial infections caused by specific pathogens, including: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections (mild to moderate), chronic bacterial prostatitis, complicated and uncomplicated urinary tract infections (mild to moderate) and acute pyelonephritis (mild to moderate).
LEVAQUIN is available in 250 mg, 500 mg and 750 mg doses in both oral and I.V. formulations. The safety profile of LEVAQUIN is similar across doses. LEVAQUIN is marketed to healthcare providers by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil, Inc.