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Daiichi Pharmaceutical (USA) Introduces FLOXIN Otic SINGLES (ofloxacin otic) Solution 0.3% For Treatment Of Common Ear Infections


10/19/2005 5:11:15 PM

MONTVALE, N.J., May 10 /PRNewswire-FirstCall/ -- Daiichi Pharmaceutical Corporation announced today that FLOXIN(R) Otic (ofloxacin otic) solution 0.3% is now available in a convenient, new single-dispensing container (SDC), known as FLOXIN(R) Otic SINGLES(TM). FLOXIN Otic SINGLES is the first and only ototopical antibiotic to be delivered in a pre-measured SDC. Each ready-to- use FLOXIN Otic SINGLES SDC delivers 0.25mL of ofloxacin otic solution 0.3%, which is equivalent to five drops from either a 5mL or 10mL bottle of FLOXIN Otic.

The new package design will provide caregivers with a simpler, more convenient means of administration while delivering a proven effective antibiotic for the treatment of ear infections.

FLOXIN Otic is the only topical treatment approved by the FDA for all three of the following ear infections: Otitis Externa (OE), (also known as "swimmer's ear"), Acute Otitis Media with Tympanostomy Tubes (AOM-TT), and Chronic Suppurative Otitis Media (CSOM) due to the most common pathogens associated with these infections. FLOXIN Otic is the only ototopical antibiotic that is FDA-approved for once-daily treatment of OE.

"The introduction of FLOXIN Otic SINGLES is very timely," said Stanley Block, MD, Professor of Clinical Pediatrics at University of Kentucky at Lexington, and President, Kentucky Pediatric Research. "As the summer season approaches, we begin to observe a significant increase in patients affected by swimmer's ear. The availability of a convenient single-dispensing container of FLOXIN Otic will be especially beneficial to parents with young children, because frequent administration of medication to young children can be challenging."

Each box of FLOXIN Otic SINGLES contains 20 SDCs, which is equivalent to one 5mL bottle of FLOXIN Otic. One SDC delivers 0.25mL of FLOXIN Otic.

"Our goal at Daiichi is to continue to find ways to enhance the patient's quality of life," said Jim Hageman, President and Chief Executive Officer, Daiichi Pharmaceutical Corporation. "Daiichi is pleased to introduce our customers to the unique benefits of FLOXIN Otic SINGLES. The doctor can prescribe FLOXIN Otic SINGLES knowing the patient will get an accurate dose without having to count drops. Both doctors and patients have the peace of mind of knowing the correct amount of medication has been administered."

About FLOXIN Otic

Developed and marketed by Daiichi Pharmaceutical Corporation, FLOXIN Otic (ofloxacin otic) solution 0.3% first received FDA approval in 1997. To date, more than six million prescriptions have been dispensed in the U.S. It is currently indicated for Otitis Externa (OE) in patients aged six months and older due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus; Acute Otitis Media with Tympanostomy Tubes (AOM-TT) in patients one to 12 years of age with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, P. aeruginosa, S. aureus, and Streptococcus pneumoniae; and Chronic Suppurative Otitis Media (CSOM) in patients 12 years of age and older with perforated tympanic membranes due to Proteus mirabilis, P. aeruginosa, and S. aureus.

Important Safety Information

The most common reported adverse reactions in three clinical trials (n=799) in OE patients treated once daily with FLOXIN Otic were application site reaction (0.6%-16.8%), pruritus (1%-1.2%), earache (0.6%-0.8%), dizziness (0.0%-0.6%), and headache (0.2%-0.3%). In two of these clinical studies (n=310), the higher application site reaction rate resulted from the specific questioning of subjects.

The most common reported adverse reactions in clinical trials in AOM patients with TT and CSOM patients treated twice daily with FLOXIN Otic (n=656) were taste perversion (7%), earache (1%), pruritus (1%), paraesthesia (1%), rash (1%), and dizziness (1%).

FLOXIN Otic is contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones, or other ingredients of the medication. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving systemic quinolones. At the first sign of allergic reaction, stop taking the drug. Patients who have not improved after one week of treatment should be evaluated by their healthcare provider.

About Daiichi Pharmaceutical Corporation

Daiichi Pharmaceutical Corporation (DPC) is a wholly owned U.S. subsidiary of Tokyo-based Daiichi Pharmaceutical Co., Ltd., one of Japan's leading research-based pharmaceutical companies. Located in Montvale, NJ, DPC is committed to putting patients first in the development of innovative, targeted therapies that fulfill unmet healthcare needs. DPC believes innovation is the key to achieving significant improvements in the treatment of diseases, the economics of disease management and patient quality of life.

For full prescribing information on FLOXIN Otic and FLOXIN Otic SINGLES, visit http://www.daiichius.com/ or http://www.floxinotic.com/

Media Contact: Gary Deeb Sr. Director, Corporate Communications Tel: (201) 573-7227 GaryDeeb@DaiichiUS.com

Daiichi Pharmaceutical Corporation

CONTACT: Gary Deeb, Sr. Director, Corporate Communications, DaiichiPharmaceutical Corporation, +1-201-573-7227, GaryDeeb@DaiichiUS.com


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