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FDA Approves New Omnicef (Cefdinir) Oral Suspension Dosage for Pediatric Use

ABBOTT PARK, IL -- September 28, 2004 -- Abbott Laboratories (NYSE: ABT) announced today that a new FDA-approved 250mg/5mL dosing option of the antibiotic Omnicef® (cefdinir) Oral Suspension (OS) is available for use in pediatric patients six months to 12 years old. The more concentrated 250mg/5mL formulation allows parents to administer fewer teaspoons per dose of the antibiotic to their children. When using the 250mg/5mL formula, parents administer half of the volume as compared to the standard formula (125mg/5mL). For example, a 40-pound child would require one teaspoon of Omnicef 250mg/5mL, instead of two teaspoons of the 125mg/5mL.

Omnicef OS is proven to effectively treat mild to moderate bacterial infections such as ear infections, sinus infections, strep throat and skin infections. "For children who need a liquid antibiotic formulation, this new dosage allows physicians to prescribe less volume per dose, reducing the overall amount of medication administered," said Manford Gooch, M.D., an adjunct professor at the University of Utah School of Medicine. "Importantly, it retains Omnicef's attractive qualities, including the flexibility of being taken without regard to meals and without refrigeration and it still has the same strawberry flavor."

The U.S. Food and Drug Administration (FDA) based its approval on the supplemental new drug application filed by Abbott on March 26, 2004. Omnicef OS was originally approved in 1997 at 125mg/5mL to treat bacterial infections in children. Omnicef is included in many treatment guidelines, such as those published by the American Academy of Pediatrics.

The new formulation was approved based on a bioequivalence study of the Omnicef OS new 250mg/5mL dosage compared to the original 125mg/5mL. To be considered bioequivalent, the two dosage formulations must perform the same when given under similar conditions in clinical studies.

"Omnicef Oral Suspension has been proven to effectively treat bacterial infections in children, and we're pleased that we can offer parents a new option that allows them to give their children less volume at each dose," said Scott Brun, M.D., divisional vice president, Infectious Disease Drug Development, Abbott Laboratories. "This concentrated formula will be more convenient for parents to administer and easier for children to take all of their medication."

About Omnicef

Omnicef Oral Suspension is indicated for pediatric patients (ages six months to 12 years) for the treatment of mild to moderate infections, including acute bacterial otitis media due to Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only) and Moraxella catarrhalis (including beta-lactamase producing strains); and pharyngitis/tonsillitis due to Streptococcus pyogenes. Omnicef is effective in the eradication of Streptococcus pyogenes from the oropharynx. Omnicef has not, however, been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Omnicef oral suspension is also indicated for the treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus (including beta-lactamase producing strains) and Streptococcus pyogenes.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omnicef and other antibacterial drugs, Omnicef should be used only to treat or prevent infections that are strongly suspected to be caused by susceptible bacteria.

Omnicef is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Patients with previous hypersensitivity to penicillins should be closely monitored when taking Omnicef. If allergic reaction to Omnicef occurs, the drug should be discontinued. In clinical studies, Omnicef was well tolerated. In pediatric trials, the most common adverse events were: diarrhea (8 percent), rash (3 percent) and vomiting (1 percent).

For complete details, please see full prescribing information, which is available at http://www.omnicef.com or http://www.omnicefforkids.com.


SOURCE: Abbott Laboratories

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