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FDA Extends Ortho-McNeil Pharmaceutical, Inc. Marketing Exclusivity for LEVAQUIN(R)


3/15/2007 10:03:45 AM

RARITAN, N.J., March 14 /PRNewswire/ -- The U.S. Food and Drug Administration (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(1), 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.

Important Safety Information

The most common drug-related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%). The safety and efficacy of LEVAQUIN in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. LEVAQUIN is contraindicated in persons with a history of hypersensitivity to LEVAQUIN, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions, as well as some of unknown etiology have been reported in patients receiving therapy with quinolones, including LEVAQUIN. These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

As with other quinolones, LEVAQUIN should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.

Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including LEVAQUIN, during and after therapy. This risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. The quinolone should be discontinued in patients experiencing pain, inflammation, or rupture of a tendon.

Some quinolones, including LEVAQUIN, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. LEVAQUIN should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx®* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after LEVAQUIN administration.

For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full Prescribing Information at www.levaquin.com About Ortho-McNeil, Inc.

Ortho-McNeil, Inc., is committed to providing innovative, high-quality prescription medicines, education and resources for patients, healthcare providers, and other members of the healthcare community in primary care, specialty and hospital settings. Based in Raritan, NJ, Ortho-McNeil markets internal medicine products in the areas of gastrointestinal and infectious diseases and pain management. PriCara, Unit of Ortho-McNeil, Inc., markets products specifically in the areas of gastrointestinal and infectious diseases and pain management. For more information, visit www.ortho-mcneil.com or www.pricara.com.

*Videx is a registered trademark of Bristol-Myers Squibb Company (1) Please see the full Prescribing Information for a complete list of indicated pathogens.

Source: Ortho-McNeil, Inc.

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