Navigation Links
Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of Priority Review for Fidaxomicin for the Treatment of Clostridium difficile Infection (CDI)
Date:1/24/2011

SAN DIEGO, Jan. 24, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI. The FDA has also granted the Company's request for six-month Priority Review, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. Additionally, the FDA has informed us that it plans to discuss the NDA at a meeting of its Anti-Infective Drugs Advisory Committee currently scheduled for April 5, 2011.

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

The acceptance of the fidaxomicin NDA for filing confirms the FDA's determination that the NDA is sufficiently complete to permit a substantive review.  A Priority Review classification is granted to drugs that, if approved, have the potential to provide significant improvements compared to marketed treatments, or provide a treatment where no satisfactory alternative therapy exists. A Priority Review means that the goal for the time it takes the FDA to review a new drug application is reduced. Based on this classification, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011 for its review of the NDA.

"In Phase 3 clinical trials, fidaxomicin not only showed a high clinical cure rate, but also demonstrated a statistically significant improvement in reducing recurrences, one of the major problems in the current management of CDI," said Pedro Lichtinger, Optimer's President and CEO.  "The agency's acceptance of our NDA represents a step forward to fulfill an unmet medical need and support
'/>"/>

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

Page: 1 2 3 4

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:12/22/2014)... Mass. , Dec. 22, 2014 ... leading manufacturer of innovative dialysis products, announced today ... has cleared its System One™ to perform hemodialysis ... known as home nocturnal hemodialysis. NxStage,s® System One ... by the FDA for this indication. ...
(Date:12/22/2014)... LUXEMBOURG , Dec. 22, 2014  ConvaTec, a ... Paul Moraviec has been appointed Interim Chief Executive Officer ... Mr. Moraviec succeeds Ken Berger .  "The Board ... service in leading ConvaTec over the past three years," ... Board of Directors.  "We are confident that the company ...
(Date:12/22/2014)... , Dec, 22, 2014  Eiger BioPharmaceuticals Incorporated ... study of lonafarnib in patients with chronic hepatitis ... at the National Institutes of Health (NIH) Clinical ...  The double-blinded, randomized, placebo-controlled, dose ascending study evaluated ... and 200 mg twice daily for 28 days.  ...
Breaking Medicine Technology:NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3ConvaTec Names Paul Moraviec Interim CEO Effective December 22, 2014 2Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 2Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 3
... Adeona Pharmaceuticals, Inc. (NYSE Amex: ... serious central nervous system diseases, announced that the Company,s ... a new Phase II clinical trial to evaluate its ... multiple sclerosis (MS) patients. The Skirball Foundation and Adeona ...
... Connecticut, November 11, 2011 At RSNA ... Sectra   (NASDAQ OMX Stockholm: SECT B), ... tomosynthesis images in Sectra Breast Imaging PACS. ... PACS do not support images of this type, a dedicated ...
Cached Medicine Technology:Adeona and the Skirball Foundation Join Forces to Advance Multiple Sclerosis Research 2Adeona and the Skirball Foundation Join Forces to Advance Multiple Sclerosis Research 3Adeona and the Skirball Foundation Join Forces to Advance Multiple Sclerosis Research 4Adeona and the Skirball Foundation Join Forces to Advance Multiple Sclerosis Research 5Sectra Launches Support for Breast Tomosynthesis Images in PACS 2
(Date:12/22/2014)... As part of a company-wide ... in San Diego and surrounding areas, Golden ... care team with ongoing online training courses. , ... provided by Caregiverlist®. Caregiverlist® is “the premiere ... most reliable eldercare options, highest quality ratings and ...
(Date:12/22/2014)... LENEXA, Kan. (PRWEB) December 22, 2014 ... it will add a subscription option to their ad ... for report writing services. Customers can sign up for ... report writing hours each month at a deeply discounted ... pricing tiers, and each has a progressively discounted rate. ...
(Date:12/22/2014)... (PRWEB) December 22, 2014 ... current Ebola virus epidemic are receiving further ... government agencies, nongovernmental organizations (NGOs) and other ... ongoing, healthcare workers, emergency responders, patients and ... such as the CmTP MediDefense system ...
(Date:12/22/2014)... NY (PRWEB) December 22, 2014 ... stronger than ever, having invested more than $5 ... service members, veterans and their families. , This ... nearly a dozen nonprofits, helping with: veteran entrepreneurship; ... scholarships; and life-coaches for severely injured veterans. , ...
(Date:12/22/2014)... 2014 Give a loved one the ... of health and vitality. , For a limited time, ... anti-aging formulas in special Holiday Wellness gift packages at ... , Each bottle contains cutting-edge, proven nutritional support for ... as well as we age. , Joint ...
Breaking Medicine News(10 mins):Health News:Golden Care Partners with Nationally Recognized Caregiver Training Service 2Health News:Sagacious Consultants’ New Subscription Packages Offer Customers Additional Report Writing Options 2Health News:Sagacious Consultants’ New Subscription Packages Offer Customers Additional Report Writing Options 3Health News:Novel Biostatic Antimicrobial Technology From Clearstream-mPact Technology Partnership (CmTP) Offers Effective Protection Against Transmission of Ebola Virus 2Health News:Novel Biostatic Antimicrobial Technology From Clearstream-mPact Technology Partnership (CmTP) Offers Effective Protection Against Transmission of Ebola Virus 3Health News:Novel Biostatic Antimicrobial Technology From Clearstream-mPact Technology Partnership (CmTP) Offers Effective Protection Against Transmission of Ebola Virus 4Health News:Novel Biostatic Antimicrobial Technology From Clearstream-mPact Technology Partnership (CmTP) Offers Effective Protection Against Transmission of Ebola Virus 5Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 2Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 3Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 4Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 5Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 6Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 7Health News:You Still Have Time to Give the Gift of Health and Vitality to a Mature Loved One 2
... , WEDNESDAY, Dec. 7 (HealthDay News) -- Hispanic women ... breast cancer than non-Hispanic white women, according to a ... could explain this discrepancy, the researchers suggested. "This ... is less responsive to chemotherapy," Kathy Baumgartner, an epidemiology ...
... mastectomy (CPM), a procedure that removes the unaffected breast ... a modest increase in life expectancy, according to a ... Medicine at the University of Pennsylvania. In fact, the ... quality-adjusted life expectancy a measure of life expectancy ...
... or adults, often takes place even in the absence ... Current methods to treat such overeating in youth focus ... them to track their food intake and engage in ... therapy techniques don,t work long term, according to Kerri ...
... HealthDay Reporter , WEDNESDAY, Dec. 7 (HealthDay News) ... with low-risk prostate cancer, a new draft report released ... concluded that research on the safety of "active surveillance" ... men opt for surgery or other treatments that can ...
... Autism Speaks Chief Science Officer Geri Dawson, Ph.D. and Assistant VP, ... Speaks "Office Hour: The Doctors Are In," a monthly live web ... each month from 3:00 - 4:00 pm Eastern / 12:00 noon ... At the time of the web chat, viewers simply log in ...
... to prevent HIV infection. Called pre-exposure prophylaxis, or PrEP, it is ... exposed to the virus. Having shown great promise in recent phase ... use. Because PrEP is based on the same ... is that the dual use of these drugs will lead to ...
Cached Medicine News:Health News:Hispanic Women More Likely to Die of Breast Cancer 2Health News:Contralateral prophylactic mastectomy offers limited gains for breast cancer patients 2Health News:Contralateral prophylactic mastectomy offers limited gains for breast cancer patients 3Health News:New approach to management of overeating in children 2Health News:New approach to management of overeating in children 3Health News:Active Surveillance May Benefit Men With Low-Risk Prostate Cancer 2Health News:New Autism Speaks 'Office Hour: The Doctors Are In' monthly live web chat 2Health News:UCLA researchers suggest unconventional approach to control HIV epidemics 2Health News:UCLA researchers suggest unconventional approach to control HIV epidemics 3
Full plate covers seal all 24 MicroAmp tubes...
96-Well PCR Plate Sealing Mat...
Easy to pierce, remove using foil stripper...
Inquire...
Medicine Products: