FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract ... (ents whopresent with diarrhea following ...)

FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections

Date:10/15/2007

ents who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

When doripenem has been used investigationally via inhalation, pneumonitis has occurred. DORIBAX should not be administered by this route.

Safety and effectiveness in pediatric patients have not been established.

The most common adverse reactions (greater than or equal to 5%) observed in clinical trials were headache, nausea, diarrhea, rash and phlebitis.

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. Headquartered in Raritan, N.J., the company markets products for infectious diseases, gastrointestinal disorders, pain management, women's healthcare and urology. For more information, visit http://www.ortho-mcneil.com.

[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws
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FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract ...(ents whopresent with diarrhea following ...)