FDA Grants Approval for New Oral Solution of LEVAQUIN(R)

RARITAN, N.J., Oct. 28 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved a new, once-a-day formulation of LEVAQUIN(R) (levofloxacin) Oral Solution 25 mg/mL. The new liquid formulation provides a convenient option for adult patients who have trouble swallowing tablets. According to published data, as many as 1 in 17 people may experience trouble swallowing; this includes 25 percent of all hospitalized patients, and up to 40 percent of nursing home patients.

LEVAQUIN Oral Solution is indicated to treat infections currently approved for the tablet and intravenous formulations and is effective against Staphylococcus aureus, Streptococcus pneumoniae (including all multiple drug- resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae. The new oral solution has the same efficacy as the tablet formulation and continues to provide the flexible dosing required for renally impaired patients. LEVAQUIN oral solution should be taken one hour before or two hours after eating.

LEVAQUIN has demonstrated safety and a low incidence of gastrointestinal and central nervous system adverse events: nausea (1.2%), diarrhea (1.0%), insomnia (0.4%), dizziness (0.3%).

The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions often occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. As with other quinolones, levofloxacin 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.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx(R)* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after levofloxacin administration. For more information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full U.S. Prescribing Information or visit http://www.levaquin.com/ or http://www.ortho-mcneil.com/ .

More than 300 million patients have been treated with levofloxacin worldwide since 1993.

The research and development supporting the approval of LEVAQUIN Oral Solution was conducted by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Ortho-McNeil Pharmaceutical, Inc., also a Johnson & Johnson company, markets LEVAQUIN in the United States as well as prescription drugs in the areas of women’s health, central nervous system, pain treatment, urology and migraine headaches.

*Videx is a registered trademark of Bristol-Myers Squibb Company

Contact: Stephanie Scott

Ortho-McNeil Pharmaceutical, Inc.

(908) 218-6483

Elise Van Buskirk

GolinHarris

(312) 729-4219

Ortho-McNeil Pharmaceutical, Inc.

CONTACT: Stephanie Scott of Ortho-McNeil Pharmaceutical,+1-908-218-6483; or Elise Van Buskirk of GolinHarris, +1-312-729-4219

Web site: http://www.levaquin.com/http://www.ortho-mcneil.com/