Navigation Links
FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections
Date:3/18/2008

RARITAN, N.J., March 18 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today 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.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.)


'/>"/>
SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Pharmos Issues Letter to Shareholders
2. MichBio Issues 2007/8 Michigan Life Sciences Directory and Resources Guide
3. HHS Issues First Department-Wide Report on Personalized Health Care
4. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
5. Symmetry Medical Discloses Accounting Issues at Sheffield, UK Operating Unit and Possible Restatement
6. CCPM Issues Statement on FDAs GIVE Initiative
7. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
8. FDA Issues Approvable Letter for LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
9. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
10. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
11. Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early Communication
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2017)... Maryland (PRWEB) , ... May 22, 2017 , ... ... Olsen, joined with other leaders of the Maryland Biohealth community in developing and ... globally recognized Top 3 U.S. BioHealth Innovation Hub by 2023. ...
(Date:5/21/2017)... CA (PRWEB) , ... May 20, 2017 , ... ... tool that helps avoid the lengthy trial and error process by finding the ... It can also strengthen the doctor-patient relationship through a personalized approach to ...
(Date:5/18/2017)... ... May 18, 2017 , ... Dr. Ralph Mobbs of the ... Of Wales Private Hospital. The procedure was performed on a 46-year-old male patient ... treatments prior to undergoing surgery. , The AxioMed viscoelastic disc is a next-generation ...
(Date:5/18/2017)... ... 17, 2017 , ... NDA Partners Chairman Carl Peck, MD , announced ... Laboratories and President of Pharmaceutical Development Business Unit of Cardinal Health, has joined the ... Health, he was former Chief Operating Officer at Anaborex, Senior VP and General Manager ...
Breaking Biology Technology:
(Date:3/27/2017)... N.Y. , March 27, 2017  Catholic ... Information and Management Systems Society (HIMSS) Analytics for ... EMR Adoption Model sm . In addition, CHS ... of U.S. hospitals using an electronic medical record ... for its high level of EMR usage in ...
(Date:3/23/2017)... -- The report "Gesture Recognition and Touchless Sensing Market by Technology ... Forecast to 2022", published by MarketsandMarkets, the market is expected to be worth ... and 2022. Continue Reading ... ... ...
(Date:3/22/2017)... March 21, 2017 Optimove , ... by retailers such as 1-800-Flowers and AdoreMe, today ... Recommendations and Replenishment. Using Optimove,s machine learning algorithms, ... product and replenishment recommendations to their customers based ... predictions of customer intent drawn from a complex ...
Breaking Biology News(10 mins):