Navigation Links
FDA Issues Complete Response Letter for Ceftobiprole
Date:12/30/2009

RARITAN, N.J., Dec. 30 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.

The FDA has requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&JPRD intends to discuss the best path forward with the FDA as soon as possible.

Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. In March 2008, J&JPRD received an Approvable Letter regarding the ceftobiprole filing. J&JPRD responded to the FDA's Approvable Letter in August 2008. In November 2008, J&JPRD received a Complete Response letter, which recommended additional site audits be conducted. The Company completed those audits through a third party and included the results in its June 2009 response to the FDA's Complete Response letter.

About Ceftobiprole

Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas.

The regulatory review process is ongoing in Europe and other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole is approved in Canada, Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)

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 J&JPRD or 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 Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither J&JPRD nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.]


    CONTACTS:
    Media:  Ernie Knewitz, 908-927-2953 or Amy Firsching, 908-218-7583
    Investor Relations:  Louise Mehrotra, 732-524-6491

SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


'/>"/>
SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. ECRI Institute Issues Steris System 1 High Priority Alert and Recommendations: Free Guidance to Help Hospitals Map out Transition to Alternative Reprocessing Methods
2. U.S. Patent Office Issues Sword Diagnostics Patent for Highly Sensitive Immunodetection Technology
3. Biomatrica Launches DNAgard(TM) for Room Temperature Storage of Tissues and Cell Culture
4. Lilly Releases Latest Value of Medicine Resource Guide About Key Issues Facing the Pharmaceutical Industry
5. UPDATE: FDA Issues 22 Warning Letters to Web site Operators
6. FDA Issues 22 Warning Letters to Web Site Operators
7. United States Patent Office Issues Patent Covering the Approved Administration of Kuvan With Food
8. CMS Admits New Surety Bond and Accreditation Requirement for Home Medical Equipment Suppliers Creating Patient Access Issues
9. AACE Issues New Medical Guidelines for Proper and Ethical Use of Growth Hormone
10. Reportlinker Adds Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution: Issues, initiatives and insights for supply chain integrity
11. China National Medicines Corporation Issues Milestone Purchase Order for 12,000 STA Systems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... -- Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in ... . ... ... ... Astellas is ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
(Date:6/24/2016)... ... ... Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair ... hour by 2020 and then adjusting it yearly to increase at the same rate as ... the wage floor does not erode again, and make future increases more predictable. , The ...
Breaking Medicine News(10 mins):