Navigation Links
FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections
Date:11/25/2008

RARITAN, N.J., Nov. 26 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received a Complete Response 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.

The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.

J&JPRD and its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., are reviewing the Complete Response letter and will continue to work with the FDA to resolve questions that are outlined in the Complete Response letter.

The NDA for ceftobiprole was submitted to the FDA in May 2007, and, 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.

Ceftobiprole was approved earlier this year in Canada, and most recently it was approved in Switzerland. Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of ceftobiprole in the European Union for the treatment of complicated skin and soft tissue infections.

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.

MRSA is a type of bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacil
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. College Mental Health Expert and Sister of Student Who Died By Suicide Available to Discuss College Mental Health Issues
2. PowerBar Issues Open Call for 2008-2009 PowerBar Team Elite(TM) Athlete Sponsorship Program
3. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
4. American Red Cross Issues Blood Supply Alert
5. OSHA Issues Draft Ergonomics Guidelines on Preventing Musculoskeletal Injuries in Shipyards
6. New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
7. National Quality Forum Issues First Consensus Standards for the Treatment of Substance Use Conditions
8. Audio: New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
9. Dallas-Area Transplant Meeting Puts Spotlight on Key Issues
10. Elder Care Author Doctor Marion Launches Second National Tour to Raise Awareness About Aging & Elder Care Issues in America
11. California State PTA Issues Statement Regarding Presidents Veto of SCHIP Legislation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... (PRWEB) October 22, 2014 Losing Weight Your ... industry is staring you in the face, it certainly can ... not do your body an extra favor by doing it ... tempting crash diets. Instead, listen to your body, exercise regularly, ... Exercise is essential to losing weight; you need to exercise ...
(Date:10/22/2014)... Steven Reinberg HealthDay ... Infants who quickly add weight and length may be showing ... suggests. In adults, certain genes have been linked to ... proportionate gains in fat and lean muscle, the researchers said. ... heavier and taller. By ages 2 and 3, however, these ...
(Date:10/22/2014)... taken by Firestone officials at the company,s rubber ... spread of the disease there and could prove effective ... provides health services to about 80,000 employees, retirees, their ... Between Aug. 1 and Sept. 23, there were 71 ... That incidence rate of 0.09 percent was much lower ...
(Date:10/20/2014)... Pittsburgh, PA (PRWEB) October 20, 2014 ... new, minimally-invasive procedure that enables physicians to repair a ... , The MitraClip system, developed by ... regurgitation (MR), a progressive and life-threatening condition in which ... allowing blood to flow backward from the heart’s left ...
(Date:10/20/2014)... hc1.com today announced the launch of ... enables healthcare organizations of all sizes to immediately ... management (“CRM”) solution. , Designed from the ground ... healthcare industry, the hc1 Healthcare Relationship Cloud™ personalizes ... combining healthcare CRM, HIPAA-compliant collaboration, and real-time analytics ...
Breaking Medicine News(10 mins):Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2Health News:Tire Company Sets Standard for Ebola Care in Liberia: CDC 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 3Health News:Healthcare Relationship Management (HRM) Leader hc1.com® Launches hc1® Quick Start™ 2
... rise of the central nervous system [CNS] in animal ... worms evolved// from the same ancestor, but their CNSs ... after their lineages had split during evolution. Researchers from ... reveal that the vertebrate nervous system is probably much ...
... need to pull up its socks on health issues, lest ... leader of chronic diseases’. If the present trend continues//, 66% ... ,A study conducted by Assocham and Price ... has shown the vulnerability of the Indian population to cardiovascular ...
... focused on motivating seniors and others with Medicare to make ... the U.S. Department of Health and Human Services (HHS) and ... is titled: A Healthier US Starts Here. , ... and summer, the Medicare Prevention tour bus will visit each ...
... U.S. Food and Drug Administration (FDA) is alerting health ... broadcasts that provide emerging// drug safety information. The broadcasts, ... computers and personal audio players. ,The service ... and speed its communications concerning the safety of ...
... modern lifestyle, which puts people under constant stress, could ... kidney disease// and dementia, scientists have warned. ... eating a poor diet, drinking too much alcohol and ... of developing heart problems. ,For some people, ...
... A peptide found in human blood inhibited 60 strains ... to a study published Thursday in the journal Cell//, ... can inhibit HIV strains that have developed resistance to ... development of new HIV/AIDS drugs -- the Chronicle reports. ...
Cached Medicine News:Health News:The Origin of the Brain Lies in a Worm 2Health News:Seniors Encouraged To Make Use Of Medicare’s Freebie 2Health News:FDA Announces Audio Broadcasts on Emerging Drug Safety Information 2Health News:Modern Lifestyle Could Damage Heart 2Health News:Peptide Found in Human Blood Inhibits 60 Strains of HIV, Study Says 2
(Date:10/22/2014)... FRANCISCO , Oct. 22, 2014 Moms ... and health trackers for themselves and their kids, according ... 2014 Report: Health & Fitness Go Mobile for Moms, ... Insights Series. BabyCenter, the number 1 pregnancy and parenting ... found that 55 percent of moms surveyed say they ...
(Date:10/22/2014)... Oct. 22, 2014  With a vision to ... medications, a Global Pharmaceutical and Biotech manufacturer selects ... and turnkey solution to protect their animal health ... Photo - http://photos.prnewswire.com/prnh/20141021/153439 ... serialized and aggregated by the Xyntek and Antares ...
(Date:10/22/2014)... Influenza will affect as many as 200,000 people ... United States as high as 49,000 people.  The ... from person to person in respiratory droplets of coughs and ... death, but kills much fewer people each year than the ... fluids including sweat, saliva, blood and other bodily fluids. The ...
Breaking Medicine Technology:BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 2BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 3BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 4Xyntek and Antares Serialization Solution Protects Pets Too! 2WholeHealth Products is proud to be releasing its Influenza A and B combo test, on the heels of the announcing of its phase 2 completion of the Rapid Ebola Test 2
Visionary OFFICE™ PM offers a Windows interface featuring medical billing, appointment scheduling and patient information....
... Medical Billing system allows a practice ... It is integrated with the EMR, ... system interfaces with electronic clearinghouses for ... a set of reports, it presents ...
... Amylase CPNG3 single liquid stable reagent ... of single liquid stability to help ... and provide quick result turnaround time. ... Amylase CPNG3 reagent provides a long ...
... The Infinity Uric Acid single liquid ... the convenience of single liquid stability ... operator error and provide quick result ... the Infinity Uric Acid reagent provides ...
Medicine Products: