Navigation Links
REMOXY® New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011
Date:1/27/2011

CUPERTINO, Calif., Jan. 27, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today reported that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for REMOXY® by King Pharmaceuticals, Inc. (NYSE: KG) and the PDUFA goal date is June 23, 2011.

(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

REMOXY, based on DURECT's ORADUR® technology, is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use.  Approximately 50 million Americans suffer from persistent pain each year, according to the American Pain Foundation.

About ORADUR® Technology

ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of resisting common methods of prescription drug misuse and abuse compared to other controlled release dosage forms on the market today.

Corporate Relationships

In December 2002, DURECT licensed to Pain Therapeutics, Inc. (Nasdaq: PTIE) the right to develop and commercialize on a worldwide basis REMOXY and other oral sustained release drug candidates using the ORADUR technology which incorporate four specified opioid compounds. Under the license agreement, DURECT is reimbursed for formulation and other work performed under its agreement, and will receive additional payments if certain development and regulatory milestones are achieved with respect to the licensed drug candidates. In addition, if commercialized,
'/>"/>

SOURCE DURECT Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. REMOXY® New Drug Application Resubmitted
2. King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for REMOXY®
3. Statement From Lilly on FDA Advisory Committee Recommendation Regarding Liprotamase New Drug Application for Treatment of Exocrine Pancreatic Insufficiency
4. K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva™
5. CoreLab Partners Launches Advanced Imaging Application
6. Virtual Event Dedicated to Cutting-Edge Trends in Implantable Medical Devices Offers Sessions on Orthopedic and Cardio Applications
7. BioDrain Medical, Inc. Is Eligible for Trading on the OTCBB, Notice of Allowance on Canadian Patent Application
8. Unilife Receives SPP Applications Exceeding A$12.8 Million
9. Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication
10. HeartWare Files PMA Application for FDA Approval of the HeartWare® Ventricular Assist System for a Bridge-to-Transplant Indication
11. Pfizer Submits Applications to FDA and EMA for Use of its Pneumococcal Conjugate Vaccine, Prevnar 13®, in Adults 50 and Older
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... Dec. 17, 2014 With advancements in ... MRI market is seeing new growth, according to ... scans account for the majority of market volume, ... of images, which are creating opportunities for more sophisticated ... is growing at a rate of 4%, with ...
(Date:12/17/2014)... 2014  RXi Pharmaceuticals Corporation (NASDAQ: ... developing and commercializing innovative therapies addressing major unmet ... enrollment in its first Phase 2a study, RXI-109-1301.  ... the 1-month findings that were reported in September ... http://photos.prnewswire.com/prnh/20130917/NE80755LOGO , , , ...
(Date:12/15/2014)... DUBLIN , Dec. 12, 2014 Research and ... addition of the "Electrocardiogram (ECG) Devices - Global ... offering. http://photos.prnewswire.com/prnh/20130307/600769 ... reach US$330 million by 2016. The North ... the global market share while Europe ...
Breaking Medicine Technology:Kalorama: 3T Advancements Bringing New Growth to the MRI Market 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 4RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 5Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 2Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 3Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 4
... 29 AstraZeneca (NYSE: AZN ) announced today ... Delaware , has found that the substance patent protecting CRESTOR (RE37,314 – the ... no inequitable conduct was committed by any Shionogi employee. The court also held ... , , ...
... CINCINNATI, Ohio , June 29 Dr. Harry ... invited speaker and panel discussion participant at the 2010 Central Regional Meeting ... June 16-19, 2010 .  The 2010 CeRMACS attracted over 400 participants ... traditional chemical disciplines.   , , ...
Cached Medicine Technology:CRESTOR® Patent Upheld By US Court 2CRESTOR® Patent Upheld By US Court 3Dr. Harry J. Guttman, Esq. Invited Speaker at 2010 Central Regional Meeting of the American Chemical Society 2
(Date:12/19/2014)... death from "rat-bite fever" of a 10-year-old San Diego boy ... a report from the U.S. Centers for Disease Control and ... illness that should be considered in persons with rash, fever ... is reported," said a team led by Dr. Jessica Adam ... in the report occurred in August of 2013. Adam,s ...
(Date:12/19/2014)... Randy Dotinga ... News) -- Common painkillers, including ibuprofen, might slightly reduce ... researchers say. Use of ibuprofen (Advil, Motrin) and ... cell skin cancer by 15 percent, the researchers concluded ... is usually caused by sun exposure. ...
(Date:12/19/2014)... THURSDAY, Dec. 18, 2014 (HealthDay News) -- Prostaglandin analogue ... -- significantly reduce the risk of vision loss in ... British researchers led by David Garway-Heath, of the ... London, tracked outcomes for more than 500 people newly ... of the disease and one of the leading causes ...
(Date:12/17/2014)... 2014 While countless companies tempt patients to ... the potential dangers of their purchase. Not only is the ... qualified doctor, but patients who buy hCG online are typically ... is actually no real hCG present. Illegal internet hCG is ... no safety standards and may contain unknown fillers that can ...
(Date:12/17/2014)... Mass. (PRWEB) December 17, 2014 ... of Osteopathic Medicine (ACOM), which welcomed its inaugural ... Desktop Infrastructure (VDI) to seamlessly support bring your ... – and teaching – experience. The solution, comprised ... NetScaler , Dell server and storage infrastructure ...
Breaking Medicine News(10 mins):Health News:Scratch From Pet Rat Kills Child; CDC Warns of Risk 2Health News:Common Painkillers May Help Prevent Certain Skin Cancers, Study Finds 2Health News:Common Painkillers May Help Prevent Certain Skin Cancers, Study Finds 3Health News:Study Supports Benefit of Widely Used Glaucoma Drug 2Health News:Diet Doc Reveals the Real Dangers for Those who Buy hCG Online 2Health News:Diet Doc Reveals the Real Dangers for Those who Buy hCG Online 3Health News:Alabama College of Osteopathic Medicine Deploys Desktop Virtualization Solution from Citrix, Dell and Unidesk 2Health News:Alabama College of Osteopathic Medicine Deploys Desktop Virtualization Solution from Citrix, Dell and Unidesk 3
... DDS, and her staff will be racing to save lives ... of Baltimore,s 2009 Susan G. Komen Race for the Cure. ... Team Chincheck has raised more than $4,700 for breast cancer ... affected by breast cancer and witnessing their strength and courage ...
... some parents may be lukewarm to the H1N1 vaccination, ... of Southern California,s largest integrated, comprehensive healthcare organizations, reports ... access to the vaccine. In response, Lakeside Community Healthcare ... patients direct access to the information they need to ...
... ... tourism industry, announced the addition of certain providers of Sistemas Medicos Nacionales, S.A. de C.V. ... ... , a global health care company in the emerging medical tourism industry, announced the addition ...
... Oct. 14 Usinas,Siderurgicas de Minas Gerais S.A. - USIMINAS (OTC: USNZY) (BOVESPA: USIM3,USIM5, USIM6) ... Third Quarter 2009 Results Conference Call. Results will be, ... after Bovespa,s trading session., ... third quarter 2009 results, ...
... Peter Sheldon, Vice President of Operations for Coverall Health-Based ... will be a featured speaker at the Professional Retail ... on October 14-15 at The Fairmont Hotel in Dallas, ... Best in Your Business with Best Practices." Sheldon will ...
... Terumo ... the latest developments in its advanced DuraHeart™ Left-Ventricular Assist System at the 23rd Annual ... , ... Mich. (PRWEB) -- Terumo Heart, Inc., a wholly owned subsidiary of Terumo Corporation, today ...
Cached Medicine News:Health News:Team Chincheck Goes Miles for Smiles 2Health News:Leading Southern California Physicians Report Patient Fears About Complexities of Flu Season 2Health News:SIMNSA is added to the Satori Global Network™ in Mexico to Offer U.S. Employers Cross Border Health Benefit Options 2Health News:Webcast Alert: Usinas Siderurgicas de Minas Gerais S.A. - USIMINAS Announces Third Quarter 2009 Results Webcast 2Health News:Coverall Executive Peter Sheldon To Be Featured Speaker at PRSM Mid-Year Conference 2Health News:DuraHeart™ Third-Generation Left Ventricular Assist System Featured at 23rd Annual Meeting of the European Association for Cardio-thoracic Surgery 2Health News:DuraHeart™ Third-Generation Left Ventricular Assist System Featured at 23rd Annual Meeting of the European Association for Cardio-thoracic Surgery 3
... This battery-powered, single-use, ... adjustable current settings: 0.5, ... uses a subdermal needle ... electrode. A "current flow" ...
... Versatile, pocket-size peripheral nerve ... a full-function nerve locator ... monitor, depending upon which ... attached. Includes NSL-5 electrode ...
Pocket-size digital nerve locator optimizes ease and convenience of performing peripheral nerve blocks. Includes RBW-5L electrode lead set, 9V alkaline battery, and durable molded polyethylene carryi...
The Lone Star Retractor System may be adapted to a specific region of the anatomy by simply adjusting the hinges. The system also includes multiple ring shapes, slots on perifephery of retractor ring...
Medicine Products: