Navigation Links
Optimer Announces that the U.S. Food and Drug Administration's Anti-Infective Drugs Advisory Committee Voted Unanimously to Recommend Approval of Novel Antibiotic Dificid™ for Treatment of Patients with Clostridium difficile infection (CDI)
Date:4/5/2011

SAN DIEGO, April 5, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) recommended that the FDA approve Optimer's investigational antibiotic DIFICID™ (fidaxomicin) for the treatment of patients with Clostridium difficile infection (CDI), a bacterial infection in the lining of the gut that can cause severe diarrhea, colitis and in some cases death. In a unanimous 13-0 decision, the AIDAC found that the clinical evidence submitted by Optimer demonstrated the safety and effectiveness of DIFICID for the treatment of CDI.

(Logo:  http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)

"We view the vote of the FDA's panel of expert advisors, with diverse backgrounds ranging from infectious disease to biostatistics, as a strong endorsement for approving DIFICID for the treatment of CDI. We are encouraged that the advisory committee recognizes the urgent need for new treatment options for CDI and the seriousness of the increasing incidence of these infections," said Pedro Lichtinger, President and CEO of Optimer. "We are proud to be one step closer to providing patients, healthcare providers and physicians with a new treatment option for CDI, a serious and debilitating disease that can impact every aspect of a patient's life."

The FDA is not bound by the committee's guidance but takes its advice into consideration. Optimer submitted its New Drug Application (NDA) for DIFICID on November 30, 2010. The FDA accepted the DIFICID NDA filing and granted a six-month Priority Review in January 2011, assigning a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011.

"In Phase 3 clinical studies, DIFICID was proven to be as
'/>"/>

SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Optimer Pharmaceuticals Receives Production Patent for Lead Product Candidate Fidaxomicin
2. Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection
3. Data From Optimers Second Phase 3 Study of Prulifloxacin Presented at Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
4. Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI)
5. Optimer Pharmaceuticals to Present at the 21st Annual Piper Jaffray Health Care Conference
6. Optimer Pharmaceuticals to Present at the 28th Annual J.P. Morgan Healthcare Conference
7. Optimer Pharmaceuticals Fidaxomicin Marketing Authorization Application Accepted for Review by European Medicines Agency
8. Optimer Pharmaceuticals to Present at September 2010 Investor Conferences
9. Optimer Pharmaceuticals Announces Presentations of Additional Fidaxomicin Phase 3 Data at Upcoming ICAAC Annual Meeting
10. Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA
11. Optimer Pharmaceuticals to Host Investor and Analyst Event on November 18
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2015)... EAST HANOVER, N.J. , April 24, 2015  Novartis ... diversity for the second year in a row on the ... the results of its 2015 Top 50 Companies for Diversity ... New York, NY . NPC also ranked second on ... on the Top 10 Companies for Employee Resource Groups list. ...
(Date:4/24/2015)... , April 24, 2015 /CNW/ - T-Bird Pharma ... focused on developing premium quality medical marijuana products and ... Marihuana for Medical Purposes Regulations ( Canada ... with certain of its shareholders, has closed the transaction ... ("Medna").  Medna has acquired (the "Escrow Transfer") a total ...
(Date:4/23/2015)... Ill. , April 24, 2015  AbbVie (NYSE: ... and Drug Administration (FDA) has accepted its New Drug ... all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ... the treatment of adults with chronic genotype 4 (GT4) ... is the first all-oral, interferon-free therapy being evaluated by ...
Breaking Medicine Technology:Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 2Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 3Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 4T-Bird Pharma Inc. Announces Closing of Transaction with Medna Biosciences 2T-Bird Pharma Inc. Announces Closing of Transaction with Medna Biosciences 3U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 2U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 3U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 4U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 5U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 6U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 7
... LAKES, N.J., Jan. 11 BD (Becton, Dickinson and Company) (NYSE: ... live webcast of its first fiscal quarter 2010 earnings conference call ... will issue a press release detailing the quarter,s earnings earlier that ... slides, will be accessible through BD,s website at www.bd.com/investors ...
... , WASHINGTON, Jan. ... that Major League Baseball star Aaron Boone is featured in ... public affairs television program that tells the compelling and inspirational stories of ... television stations nationwide. It is sponsored by the Pharmaceutical Research and ...
Cached Medicine Technology:BD Announces Live Webcast of First Fiscal Quarter Earnings Conference Call 2Major League Baseball Star Aaron Boone on 'Sharing Miracles' 2Major League Baseball Star Aaron Boone on 'Sharing Miracles' 3
(Date:4/25/2015)... 25, 2015 The Hon. Ellen Tauscher, ... issues the following statement following the deadly earthquake in ... Nepal, resulting in the deaths of more than 1,000 ... felt across Nepal, Bangladesh, India and other parts of ... condolences to the people of Nepal and the families ...
(Date:4/25/2015)... (PRWEB) April 25, 2015 By definition, a ... data for the enterprise relying on their judgement and expertise ... But according to an article published in National ... times actually be doing a disservice to their responsibilities by ... dotted and t’s are crossed when it comes to company ...
(Date:4/25/2015)... 25, 2015 Parker and Sons projects growth ... has spiked in Arizona alongside the growing economy. As a ... employees for April to help account for the rising need ... in April is something we are enthusiastic about. It means ... Kelly, president at Parker and Sons. , Indeed, Parker and ...
(Date:4/25/2015)... For thirteen years, the Twin Cities DI Day has been ... nation! This year, on May 5th, 2015, Secura Consultants is ... Day on the road by supporting the first ever National ... CLTC, Chief Executive Officer at Secura Consultants and co-creator of ... stating, "The first Twin Cities DI Day was a hugely ...
(Date:4/24/2015)... (PRWEB) April 24, 2015 As the ... and the unique sacrifices of these young men and ... Service members, Veterans and their Families” presents a special ... is designed to gain a better understanding of the ... and wellness. For those – civilian and military – ...
Breaking Medicine News(10 mins):Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 2Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 3Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 4Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 5Health News:Parker and Sons Plans to Expand in 2015 2Health News:Secura Consultants Takes DI Day On The Road 2Health News:Coalition Presents Resiliency Training to Raise Awareness during Month of the Military Child (#MOTMC2015) 2
... ... MRSA. Jan-Pro, Global Leader in Commercial Cleaning, Once Again Leads the Way in Infection ... Solution in the control of infectious microorganisms - EnviroShield Disinfectant Technology , ... (PRWEB) June 1, 2010 -- ...
... , ... of Midbrook, Inc.) is proud to announce they have recently been awarded an agreement with ... the nation’s largest healthcare group purchasing organizations and serves 2,300 hospitals and more than 66,000 ... ...
... GIA announces the ... Proteins market is anticipated to reach 472.3 million pounds by 2015, driven largely by functional ... processing and investments in R&D are other major driving forces for the growth of the ... San ...
... ... purchase used equipment from CosmeticLaserWorld.com can now rely on a brand new buy back ... (PRWEB) ... and doctors, recently unveiled yet another reason savvy spas should purchase equipment from the ...
... resulting from an inherited defect that prevents the proper metabolism ... milk. Exposure of affected people to galactose, can damage most ... to study the disease is limited by a lack of ... and flies may provide scientists with useful clues. The ...
... The American College of Radiology,s (ACR) Task Force on ... Organizations has proposed several steps that can help improve ... they service, according to an article in the June ... of Radiology ( www.jacr.org ). "The ...
Cached Medicine News:Health News:JAN-PRO Launches Exclusive “EnviroShield™” Disinfecting System - Kills Harmful Bacteria, Including MRSA 2Health News:JAN-PRO Launches Exclusive “EnviroShield™” Disinfecting System - Kills Harmful Bacteria, Including MRSA 3Health News:Midbrook Medical Announces Agreement with Premier Partners L.P. 2Health News:Midbrook Medical Announces Agreement with Premier Partners L.P. 3Health News:US Whey Proteins Market to Reach 472.3 Million Pounds by 2015, According to New Report by Global Industry Analysts, Inc. 2Health News:US Whey Proteins Market to Reach 472.3 Million Pounds by 2015, According to New Report by Global Industry Analysts, Inc. 3Health News:CosmeticLaserWorld.com Gives Buyers Peace of Mind Through Industry-Leading Investment Protection Plan 2Health News:Flies offer insight into human metabolic disease 2Health News:ACR task force makes recommendations for improving relationships between radiologists and hospitals 2
... and Nitrogen Blow-Down Evaporators. For over ten years TurboVap concentration technology has received enormous acclaim with over ... ... ... ...
Plastic Tray Type Vacuum Manifold...
QIAvac 6S provides all manifold components for processing QIAGEN 8-well strips....
For connecting the QIAvac 24 Plus and Vacuum Pump;...
Medicine Products: