FDA extends Levaquin marketing exclusivity

The US Food and Drug Administration has granted Johnson & Johnson subsidiary Ortho-McNeil's Levaquin (levofloxacin) an additional six months of marketing exclusivity, known as "pediatric exclusivity." The action attaches to the US patent covering the drug, extending exclusivity from December 2010 to June 2011. The 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. They were conducted in collaboration with leaders in the pediatric and infectious disease communities and the FDA.

Since its US 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 and exacerbation of chronic bronchitis, nosocomial pneumonia, CAP, 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).