Navigation Links
REMOXY(R) NDA Filing Accepted by FDA and Priority Review Granted
Date:8/12/2008

CUPERTINO, Calif., Aug. 12 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of REMOXY(R) and granted Priority Review. The FDA typically grants Priority Review to drug candidates that have the potential to demonstrate significant improvements compared to marketed products. The FDA goal for completing review of a drug with Priority Review status is six months from the date the application was submitted. The REMOXY NDA was submitted to the FDA by Pain Therapeutics on June 10, 2008.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)

"We are pleased that the NDA has been accepted and that REMOXY will receive Priority Review," stated James E. Brown, DVM, President and CEO of DURECT. "The abuse of pain medications is a widespread problem in this country and addressing that issue is clearly in the public interest. We're delighted that our ORADUR(TM) technology has enabled the development of REMOXY, an investigational drug that has the potential to be the first oxycodone on the market that deters common methods of abuse."

REMOXY is being developed by Pain Therapeutics (Nasdaq: PTIE) under license from DURECT, and Pain Therapeutics has, in turn, sublicensed the commercialization rights for this drug candidate to King Pharmaceuticals (NYSE:

SOURCE DURECT Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Lixte Biotechnology Holdings Announces Filing of a New Patent Application for the Use of Novel Compounds as Potential Treatment for Neurodegenerative Diseases
2. CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
3. Embryo Viability Studies Support Utility of Novel, Metabolomic Profiling Technology
4. ISTA Pharmaceuticals Announces New Phase III Clinical Findings to Support Bepreve NDA Filing
5. Preclinical Study Shows CTIs Brostallicins Cancer-Killing Ability Based on Genetic Profiling
6. Oncology Drug Development Update - Molecular Profiling Redefines the Nature of Malignancy and Increases the Adoption of Targeted Therapeutics
7. Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
8. Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System
9. Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA
10. Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
11. Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/31/2015)... CORAL SPRINGS, Fla. , March 31, 2015 ... technology (HIT) strategy and management consulting firm, has ... reference publication to enable health IT vendors, payers ... environment for the electronic prior authorization (ePA) of ... prescription prior authorization (PA) requests are completed through ...
(Date:3/31/2015)... March 31, 2015 The Medical Letter ... in the American Medical Group Association,s "High Performing ... AMGA,s "High Performing Health" production is an ... the nation,s healthcare system in delivering better care ... along with other leading organizations in the healthcare ...
(Date:3/31/2015)... 2015 RnRMarketResearch.com adds "Pemphigus ... report of 68 pages with latest updates, data ... The report "Pemphigus - Pipeline Review, H1 2015" ... development for Pemphigus , complete with comparative analysis ... mechanism of action (MoA), route of administration (RoA) ...
Breaking Medicine Technology:Point-of-Care Partners Launches the ePA State Navigator 2AMGA's High Performing Health News Program Features The Medical Letter 2Pemphigus Therapeutic Development and Pipeline Review H1 2015 2Pemphigus Therapeutic Development and Pipeline Review H1 2015 3Pemphigus Therapeutic Development and Pipeline Review H1 2015 4
... March 15, 2010 ,Essilor International has acquired FGX International Holdings Limited, the,North American market leader in the design and sale of non-prescription,reading glasses. The transaction was completed following ... ... ... ...
... Siemens Healthcare addresses the clinical and business needs ... of the American College of Cardiology (ACC), March 14-16 ... commitment to excellence, Siemens empowers its customers with the necessary ... help them meet their strategic and metric goals. Siemens, complete ...
Cached Medicine Technology:Essilor Acquires FGX International, Becoming a Major Player in a New Fast-Growing Market 2Essilor Acquires FGX International, Becoming a Major Player in a New Fast-Growing Market 3Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 2Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 3Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 4Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 5Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 6Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 7Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 8Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 9Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 10Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 11Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 12Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 13Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010 14
(Date:4/1/2015)... CA (PRWEB) April 01, 2015 San ... and the international children’s medical charity, Operation Smile, ... new global partnership. , Campaign Details: RxOrganics is ... Rxmedical line to Operation Smile throughout 2015. RxOrganics ... on such sales so that every order placed online ...
(Date:4/1/2015)... TCS Healthcare Technologies (TCS), a leading ... management and population health arenas, is pleased to announce ... which is fully integrated with the ACUITY platform. , ... p.m. ET, will be led by Jeff Frater, RN, ... explore the feature-rich portal as well as the importance ...
(Date:4/1/2015)... 2015 Nike Golf Camps has expanded ... Arizona and Florida. These programs are specifically designed for ... in a golf-intensive environment and to learn about the ... of Arizona coaching legend, Rick LaRose, spends significant time ... gaps as it pertains to the recruiting and college ...
(Date:4/1/2015)... Oak Brook, IL (PRWEB) April 01, 2015 ... unfortunately benefited greatly from climate change in recent years, ... will develop an allergic reaction if exposed to poison ... as outdoor enthusiasts and families prepare for summer adventures ... of an uncomfortable poison plant reaction is greater than ...
(Date:3/31/2015)... 31, 2015 Due to its ... hire more caregivers, staffing personnel, and marketing managers, ... managers within the Greater Los Angeles area. In ... 1Heart Caregiver University has firmed up its training ... to provide quality in-home care through a client-centered ...
Breaking Medicine News(10 mins):Health News:RxOrganics Forges Unique Partnership to Bring More Smiles to Underserved Global Heath Communities 2Health News:TCS Healthcare Technologies Releases Acuity Connect 2Health News:TCS Healthcare Technologies Releases Acuity Connect 3Health News:US Sports Camps and Nike Golf Camps to Host Golf Development Camps in Arizona and Florida 2Health News:US Sports Camps and Nike Golf Camps to Host Golf Development Camps in Arizona and Florida 3Health News:New Ivarest Poison Ivy Itch Spray Provides All-Day Comfort 2Health News:1Heart Ends 1st Quarter of the Year With 1Heart Caregiver University Training of New Staff and Commits To Provide More Jobs For Year 2015 2Health News:1Heart Ends 1st Quarter of the Year With 1Heart Caregiver University Training of New Staff and Commits To Provide More Jobs For Year 2015 3
... veterans face some unique health issuesMINNEAPOLIS/ST. PAUL, Minn., May ... to school this fall as a result of the ... ensure student veterans, unique needs are met, according to ... the University of Minnesota and Minnesota State ...
... Angeles, London, New Delhi, Singapore and Washington DC (May 29, 2009) ... an over-the-counter, rapid HIV test for home use, according to a ... MDM ) which is published by SAGE. , As ... are at greater risk for HIV infection will not be able ...
... DALLAS, May 29 BeaconEquity.com announces availability of alerts on ... trading. The alerts include recent news, trading activity and technical ... stock alerts for free by visiting ... Angiotech Pharmaceuticals Inc. (Nasdaq: ANPI ), Peregrine Pharmaceuticals ...
... disease, risks may outweigh benefits, research suggests , , ... attack risk in people with no previous history of ... say British researchers who analyzed the results of 22 ... this group of patients is uncertain because the benefits ...
... & Lomb,s Expanding Ocular Pharmaceuticals Portfolio and Offers New ... Pathogens(1) - , MADISON, N.J., May 29 Bausch ... announced that the U.S. Food and Drug Administration (FDA) ... the treatment of bacterial conjunctivitis, commonly referred to as ...
... at Digestive Disease Week, addressing the topic of invention of new ... ... May 29, 2009 -- Zeus, Inc., a leader in polymer extrusions ... Digestive Disease Week in Chicago on June 1, 2009. Zeus ...
Cached Medicine News:Health News:Student Veteran Health Examined in First-of-Its-Kind Study by University of Minnesota/Minnesota State Colleges and Universities 2Health News:Student Veteran Health Examined in First-of-Its-Kind Study by University of Minnesota/Minnesota State Colleges and Universities 3Health News:FDA ignores critical information on home HIV tests 2Health News:Beacon Equity Issues Stock Alerts on Leading Pharmaceutical Giants 2Health News:Beacon Equity Issues Stock Alerts on Leading Pharmaceutical Giants 3Health News:Value of Taking Aspirin to Cut Heart Risk Varies 2Health News:Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye') 2Health News:Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye') 3Health News:Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye') 4Health News:Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye') 5Health News:Zeus to Present at Digestive Disease Week in Chicago 2
Thermal Seal, Clear, Bulk...
Acetate Plate Sealers 100/Box...
... seals provide an adhesive-based sealing option for ... adhesive layer ensures secure sample storage or ... sealing during thermal cycling when supplemental pressure ... perforated end-tabs can be removed when using ...
TD silicone foam compression pad. Use with plates sealed with TDX or OptiTape....
Medicine Products: