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
'/>"/>

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

Page: 1 2

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:7/14/2014)... 2014  More than any other generation, Millennials born in ... -- but their eyes don,t. These mobile devices demand a ... the eye has not evolved to cope with them. The ... do comfortably often results in tired eyes, focusing problems, headaches ... Strain. Now ZEISS has invented a new type of lens ...
(Date:7/14/2014)... July 14, 2014  Today, ATS Labs, Inc. (ATS), ... acquired the assets of MicroTest Labs, Inc. (MTL) of ... MTL is the first step in the strategy of ... platform to support the medical device and biopharmaceutical industries. ... Accuratus Lab Services , a name that personifies the ...
(Date:7/14/2014)... , July 14, 2014  Mallinckrodt plc (NYSE: ... QCOR ) today announced that the registration statement on Form ... by Mallinckrodt plc on May 16, 2014 and amended on ... Mallinckrodt and Questcor that also constitutes a prospectus of Mallinckrodt, ... on Form S-4 is available on the SEC,s EDGAR system, ...
Breaking Medicine Technology:New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 2New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 3ATS Labs, Inc. Announces the Acquisition of MicroTest Labs, Inc. 2ATS Labs, Inc. Announces the Acquisition of MicroTest Labs, Inc. 3Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 2Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 3Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 4Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 5Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 6Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 7
... and women infected with HIV reduced the risk of ... of oral antiretroviral therapy (ART), according to findings from ... Prevention Trials Network (HPTN), a global partnership dedicated to ... and structural interventions. The study, known ...
... May 12, 2011 Alma Lasers Ltd., a ... aesthetic treatment devices, today announced the launch of ... for aesthetic fractional laser resurfacing. ... iPixelEr—each feature Alma,s roller-style technology which delivers fast, ...
Cached Medicine Technology:Initiation of Antiretroviral Treatment Protects Uninfected Sexual Partners from HIV Infection (HPTN Study 052) 2Initiation of Antiretroviral Treatment Protects Uninfected Sexual Partners from HIV Infection (HPTN Study 052) 3Initiation of Antiretroviral Treatment Protects Uninfected Sexual Partners from HIV Infection (HPTN Study 052) 4Initiation of Antiretroviral Treatment Protects Uninfected Sexual Partners from HIV Infection (HPTN Study 052) 5Alma Lasers Introduces the iPixel Fractional Ablative Technology 2
(Date:7/14/2014)... According to a recent study ... a connection between women with high levels of a ... doctors have theorized about the role stress plays in ... provide scientific support. , “Stress, if very significant, can ... Barmat, an OB/GYN who specializes in reproductive endocrinology and ...
(Date:7/14/2014)... Last month Bromell Agency officially launched the new ... more detailed information on how clients can protect and ... boats in the state of Louisiana. , The agency ... website in order to better educate clients on the ... the website, which is to display comprehensive insurance information ...
(Date:7/14/2014)... 14, 2014 There’s an old adage that ... The Lash Palette say the products offered in their ... , “You can reserve The Lash Palette for $40,” said ... Store . , Paris explained that the first 1,000 have ... 21. , She went on to point out that her ...
(Date:7/14/2014)... 2014 Seven promising startup companies ... problems have been accepted into the University ... (DHA). , The awardees were selected from ... process. They include Biomeme, Fitly, Life Patch, Curbside ... France) and Pulse InfoFrame (from Canada) —both of ...
(Date:7/14/2014)... 2014 Jordan Valley Medical Center is ... comprehensive cancer center set to open by the fall ... only hospital west of I-15 in the Salt Lake ... Additionally, Jordan Valley Medical Center has partnered with Elekta, ... planning systems for radiation therapy, radiosurgery and brachytherapy, to ...
Breaking Medicine News(10 mins):Health News:Abington Health Physician Addresses Link Between Stress and Infertility 2Health News:Abington Health Physician Addresses Link Between Stress and Infertility 3Health News:The Lash Palette Preorder Event Has Officially Begun 2Health News:Seven Healthcare Startups Selected to Participate in University City Science Center’s First Digital Health Accelerator 2Health News:Seven Healthcare Startups Selected to Participate in University City Science Center’s First Digital Health Accelerator 3Health News:Seven Healthcare Startups Selected to Participate in University City Science Center’s First Digital Health Accelerator 4Health News:Jordan Valley Medical Center Set to Break Ground with New $10 Million Cancer Center 2
... day to day life. Keeping fit costs hardly anything if ... a gym or health club,// you'll be familiar with high ... These items typically cost thousands of dollars and might be ... But you can get the same results practically for free, ...
... lasers help remove lines and wrinkled from age and ... can take its toll in later years in terms ... But, says Dr Arielle Kauvar, a dermatologist at New ... smoother, firmer appearance. ,These lasers score over ...
... of botulinum toxin eases hand spasticity among stroke survivors. Spasticity ... and it causes much disability,// because it interferes with activities ... botulinum toxin - a substance that relieves muscle tightness - ... large trial of botulinum toxin (also known as botox) in ...
... may be combined with tumor growth in mice. At ... or similar pain medications will lead to increased cancer ... further studies for managing cancer pain. ,Researchers ... of morphine, similar to doses given to cancer patients ...
... potency can be influenced by various reasons. Many advertisments ... impotence to the attention of thousands of people.// Impotence ... men are taking help, particularly as large segments of ... range from 12 million to 30 million men in ...
... An acid found naturally in the body can block the ... There is no cure for Huntington's disease (HD), which is ... But researchers at the University of Texas may be one ... with HD. ,The mice were treated with a ...
Cached Medicine News:Health News:Many factors influence sexual potency 2
... Cronin, Inc. is a ... Footwear, Orthopedic Softgoods, and ... Our products are of ... available in the USA ...
... ThumbFit™ reduces joint instability without disturbing ... remarkably comfortable and easy for users ... CHT and Robert V. Sypher Jr., ... in response to patients' complaints of ...
... the MP joint and the CMC joint of the ... both of the thumb joints. An excellent choice for ... who need maximum mobility for daily activities. Ideal for ... and for those with pain due to repetitive stress. ...
... molded from rigid plastic in a distinctive design ... comfort. The uniquely sculpted distal trim line ... maximum function of the hand. This is ... and sprains of the MCP joint, basal joint ...
Medicine Products: