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J&JPRD, along with its co-development partner, Swiss-based BasileaPharmaceutica Ltd., is reviewing the agency's letter and will work quickly toresolve any outstanding issues. The NDA for ceftobiprole was submitted to theFDA last May.
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An application for the use of ceftobiprole in adults in the sameindication is currently under regulatory review in Europe, Australia, Canadaand in other countries.
J&JPRD is part of Johnson & Johnson, the world's most broadly basedproducer of healthcare products. J&JPRD is headquartered in Raritan, NJ, andhas facilities throughout Asia, Europe and the United States. J&JPRD isleveraging drug discovery and drug development in a variety of therapeuticareas to address unmet medical needs worldwide.
(This press release contains "forward-looking statements" as defined inthe Private Securities Litigation Reform Act of 1995. These statements arebased on current expectations of future events. If underlying assumptionsprove inaccurate or unknown risks or uncertainties materialize, actual resultscould 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 ratefluctuations; technological advances and patents attained by competitors;challenges inherent in new product development, including obtaining regulatoryapprovals; domestic and foreign health care reforms and governmental laws andregulations; and trends toward health care cost containment. A further listand description of these risks, uncertainties and other factors can be foundin Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal yearended December 30, 2007. Copies of this Form 10-K, as well as subsequentfilings, are available online at www.sec.gov
SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
