FDA Issues Approvable Letter For Ceftobiprole For Treatment Of Complicated Skin Infections

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Dermatology;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 19 Mar 2008 - 0:00 PDT

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.

An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.

J&JPRD is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

(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 Johnson & Johnson'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 and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov,http://www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
http://www.jnj.com