Navigation Links
REMOXY(R) NDA Update
Date:7/7/2009

CUPERTINO, Calif., July 7 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) today reported that King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) have announced that King met with the Food and Drug Administration (FDA) on July 2, 2009 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). According to King Pharmaceuticals and Pain Therapeutics, the outcome of the meeting last week provided King with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter.

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

According to the King Pharmaceuticals / Pain Therapeutics press release, King now anticipates the resubmission of the NDA could occur mid-year 2010. King believes that the rate limiting step is the generation of six-month stability data, and no new clinical trials are required. King has stated that it remains committed to the development and commercialization of REMOXY and looks forward to working closely with the FDA toward approval of the product.

REMOXY, based on DURECT's ORADUR(TM) 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. In mid-2008, an NDA for REMOXY was accepted by the FDA and was granted Priority Review. In December 2008, Pain Therapeutics received a Complete Response Letter from the FDA. Subsequent to the receipt of the Complete Response
'/>"/>

SOURCE DURECT Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Pain Therapeutics Receives Complete Response Letter From FDA for REMOXY(R)
2. FDA Updates Prescription Guidelines for Blood Thinner
3. PreMD Provides Update on 510(k) Application for PREVU(x) POC
4. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
5. PA Game Commission: EHD Outbreak Update: Test Results Confirm EHD In Beaver County
6. Updated GOLD report presents new understandings in diagnosis, treatment and prevention of COPD
7. Cardinal Health Reaffirms Fiscal 2008 EPS Guidance, Updates Segment Profit Outlook
8. Update on Jill Finley Story, Coma Survivor
9. Billians HealthDATA Completes Comprehensive Long Term Care Database Update
10. Labopharm provides update on U.S. regulatory process for once-daily Tramadol
11. Updated Brochure on Gynecologic Cancer Treatments Now Available
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... is a famous wedding dress company offering many trendy designs. ... Facebook, Twitter, and Pinterest. The fans will have an opportunity ... every week. , Moreover, the company has extended its 2015 ... homepage for more information. , Angelweddingdress is a ...
(Date:1/22/2015)... January 22, 2015 A new white ... experience and person-centeredness in the long-term care environment as ... across the continuum. The paper, “The Power of Person-Centeredness ... perspectives and practices of the patient, resident and family ...
(Date:1/22/2015)... NJ (PRWEB) January 22, 2015 Joan ... and keynote speaker at the upcoming 32nd Annual ... ACCME-accredited Physicians’ Education Resource®, LLC (PER®) , shares ... would have gone undetected if she had not followed ...
(Date:1/22/2015)... 2015 Four years since the release of their ... with the marriage of Avasa & Matthew Love – the duo ... scheduled for release through White Swan Records on February 24, 2015. ... a sacred path available to all of us to walk out ...
(Date:1/22/2015)... Compare-autoinsurance.org has released a new blog post presenting a list ... policy . , Some types of vehicles cannot be covered ... released blog post to see if their vehicle qualifies for auto ... some of the cars that cannot be covered by a plan. ...
Breaking Medicine News(10 mins):Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2
... The Association of Flight Attendants-CWA (AFA-CWA) today testified ... recent public health emergency and the summer travel outlook ... Subcommittee on Aviation conducted the hearing which focused on ... health emergencies."We strongly believe that we must be given ...
... On May 20, 2009, the US District Court for ... (NYSE: AZN ) for an injunction barring Apotex ... of AstraZeneca,s PULMICORT RESPULES (budesonide inhalation suspension) in the US. ... set.On March 30, 2009, the US Food and Drug Administration ...
... 20 TouchMark a division of Delphon Industries ... Pad Printing, announced today the appointment of Diablo ... sales support in the western United States and ... of the leading manufacturers, representative organizations specializing in ...
... Adults Say They,ve Been Examined For Skin CancerYONKERS, N.Y., May 20 ... Reports National Research Center said ... sun,s risks: 22 percent of those polled said they,d been examined ... The July issue of Consumer Reports rates ten ...
... WASHINGTON, May 20 Catholic hospitals in the ... abortions in a joint medical venture between Centene ... http://www.newscom.com/cgi-bin/prnh/20081105/DC44231LOGO )In the midst of growing anxiety over ... hospitals and charities, many dioceses are scrambling to ...
... WEDNESDAY, May 20 (HealthDay News) -- A new gene variant ... has been identified by U.S. researchers. , Analysis of the ... sons affected by autism revealed that a variant of the ... autism, the researchers reported. , This variant of the gene, ...
Cached Medicine News:Health News:Association of Flight Attendants-CWA Testifies on Emergency Planning After Recent Flu Outbreak 2Health News:Court Grants AstraZeneca Preliminary Injunction Against Apotex in PULMICORT RESPULES Patent Litigation 2Health News:TouchMark Announces New Sales Representative 2Health News:Consumer Reports Poll: Thirty-One Percent of Americans Never Use Sunscreen 2Health News:Consumer Reports Poll: Thirty-One Percent of Americans Never Use Sunscreen 3Health News:Consumer Reports Poll: Thirty-One Percent of Americans Never Use Sunscreen 4Health News:ALL: Boston Archdiocese Reportedly on Track for Abortion Referring Venture 2Health News:Gene Gives Clues to Why Autism More Common in Boys 2
(Date:1/23/2015)... More than a third of reproductive-aged women enrolled in ... insurance, filled a prescription for an opioid pain medication each ... Morbidity and Mortality Weekly Report (MMWR). Opioids ... to severe pain.  They are also found in some prescription ...
(Date:1/23/2015)... YORK , Jan. 23, 2015 /PRNewswire/-- Harwood Feffer LLP ... board of directors of Advaxis, Inc. ("Advaxis" or the ... board has breached its fiduciary duties to shareholders. ... on an investing website reporting that Advaxis had misrepresented ...
(Date:1/23/2015)... GAINESVILLE, Fla. , Jan. 23, 2015  HyGreen, Inc., ... distribution agreement and partnership with RCA Medical, a subsidiary ... Africa . Each year, hundreds of ... health care-associated infections as organisms are transmitted from patient ...
Breaking Medicine Technology:Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2HyGreen Partners with RCA Medical in Johannesburg, South Africa 2
... from Cytel join peers in examining the rise of ... ... CAMBRIDGE, Mass., June 23 Cytel,s renowned adaptive,trial design and implementation ... will lead workshops and case,study reviews at the Annual Meeting of ...
... 23 Alexza,Pharmaceuticals, Inc. (Nasdaq: ALXA ) ... Phase 2a clinical trial of Staccato(R) loxapine (AZ-104) ... Annual Scientific Meeting of,the American Headache Society, which ... Boston, MA. The oral platform abstract presentation,"Inhaled Loxapine, ...
Cached Medicine Technology:Cytel's Clinical Innovation Experts Cyrus Mehta and Judith Quinlan Reveal Latest Adaptive Trial Successes at 44th Annual DIA Meeting 2Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting 2
Straight shafts with curved 1 x 2 teeth. Serrated handle with polished finish....
Straight shafts with fine Pierse type tips. Flat smooth handle with dull finish....
Serrated handle with polished finish. Straight tips: Delicate 11 mm. Most popular size or model....
1 x 2 teeth, cross serrated 5 mm 60 degree angled platform. Round knurled handle with polished finish....
Medicine Products: