Navigation Links
King and Pain Therapeutics Announce REMOXY(R) NDA Update
Date:7/7/2009

BRISTOL, Tenn. and SAN MATEO, Calif., July 7 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced that on July 2, 2009, King met with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY(R) NDA and to address all FDA comments in the Complete Response Letter.

King now anticipates the resubmission of the NDA could occur mid-year 2010. The Company believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required. King remains committed to the development and commercialization of REMOXY(R), and looks forward to working closely with the FDA toward approval of the product.

About REMOXY(R)

REMOXY, an investigational drug, is a unique, long-acting oxycodone formulation 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 Letter, King assumed full control of all activities related to the development of REMOXY(R).

About King Pharmaceuticals, Inc.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangement
'/>"/>

SOURCE King Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Cell Therapeutics Added to Russell 3000(R), Russell 2000(R) and Russell Global(R) Indexes
2. Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clearazide for Treatment of Cutaneous T-cell Lymphoma
3. Horizon Therapeutics Names Dr. Jeffrey W. Sherman Executive Vice President and Chief Medical Officer
4. PTC Therapeutics Receives $2.6 Million in Government Grants
5. Cell Therapeutics on Preliminary List of Additions to Russell 3000(R) Index and Russell Global(R) Index
6. Nektar Therapeutics Promotes Lorianne Masuoka, M.D. to Chief Medical Officer
7. CSL Limited and Talecris Biotherapeutics Agree to Terminate Merger Agreement
8. Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions
9. Orexigen(R) Therapeutics Presents Additional NB-302 Contrave(R) Data at American Diabetes Association (ADA) 69th Scientific Sessions
10. Tobira Therapeutics Inc. Announces Key Addition to Scientific Advisory Board
11. PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... PA (PRWEB) August 29, 2014 Pittcon ... Hub MacDonald, and colleague Koichiro Matsuda, Horiba Scientific, have ... on September 5, 2014. JASIS , Asia’s largest ... 3-5, 2014, in Makuhari Messe, Japan. , The ... Tools for Bioanalysis from Single Molecules to Single Cells” ...
(Date:8/29/2014)... Three Lawrence Livermore researchers have ... Production R&D Award for their research in ... sunlight. , Shared with collaborators from the National ... Nevada, Las Vegas (UNLV), the award recognizes the ... solar-hydrogen production and corrosion processes. , These models ...
(Date:8/29/2014)... August 29, 2014 Intrinsic Imaging, ... certified, GAMP® 5 compliant imaging core lab, announced ... Phase II clinical trial to assess a new ... this trial, Intrinsic Imaging will provide comprehensive imaging ... protocol and charter development, site qualification, site training ...
(Date:8/28/2014)... Ca. (PRWEB) August 28, 2014 Best ... rating for an alcohol-based hand sanitizer, asks food processors ... by comparing the hand sanitizer they’re currently using to ... . Hand hygiene is critical to fighting cross-contamination and ... Best Sanitizers believes there are key criteria that ...
Breaking Biology Technology:Fifth Annual U.S. Symposium at JASIS Organized by Pittcon’s Program Chairman Hub MacDonald 2Livermore Team Awarded for Hydrogen Production Research 2Intrinsic Imaging Awarded Phase II Clinical Trial to Assess New Treatment for Non-Hodgkin’s Lymphoma 2Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 2Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 3
... Inc. a global provider of comprehensive sample asset ... the bioscience industry, will host its Global Sample ... Expo (ICSE), on Wednesday, 26 October 2011, in ... include two 1-hour presentations from industry thought leaders ...
... Metabolex, Inc., a biopharmaceutical company focused on the discovery ... of metabolic diseases, announced today that Dr. Raymond Urbanski ... Urbanski brings extensive clinical development experience to Metabolex, including ... execution. Dr. Urbanski was the Vice ...
... Reportlinker.com announces that a new market research report ... US Microbiology Testing Market ... Comprehensive 1,087-page analysis of ... pertaining to the US microbiology laboratory practice, as ...
Cached Biology Technology:BioStorage Technologies to Host Global Sample Management Benchmarking Symposium at International Contract Services Expo 2Metabolex Appoints Raymond Urbanski M.D., Ph.D. to Position of Chief Medical Officer 2Metabolex Appoints Raymond Urbanski M.D., Ph.D. to Position of Chief Medical Officer 3US Microbiology Testing Market 2US Microbiology Testing Market 3US Microbiology Testing Market 4US Microbiology Testing Market 5US Microbiology Testing Market 6US Microbiology Testing Market 7US Microbiology Testing Market 8US Microbiology Testing Market 9US Microbiology Testing Market 10US Microbiology Testing Market 11US Microbiology Testing Market 12US Microbiology Testing Market 13US Microbiology Testing Market 14US Microbiology Testing Market 15US Microbiology Testing Market 16US Microbiology Testing Market 17US Microbiology Testing Market 18US Microbiology Testing Market 19
(Date:8/28/2014)... , Aug. 28, 2014  Privacy Advocate and ... Jennifer Lynch , joins the lineup of biometric ... second annual Biometrics UnPlugged Executive Summit in ... Previously announced speakers include Steven Rahman, Director, Technology ... Public Sector at Experian. The theme of this year,s ...
(Date:8/28/2014)... Philadelphia, PA, August 28, 2014 Dyslexia, the ... States, is a neurological reading disability that occurs ... written language don,t function normally. , The use ... how brain activity is disrupted in dyslexia. However, ... small number of brain regions, leaving a gap ...
(Date:8/28/2014)... northern California, and Alaska totaled 515 million board feet ... increase of more than 10 percent compared to the ... Northwest Research Station reported today. During this same period, ... 247 million board feet. , The total value of ... to $390 million in the same quarter, while the ...
Breaking Biology News(10 mins):Biometrics UnPlugged Welcomes the Electronic Frontier Foundation's Jennifer Lynch to the Mobility at the Crossroads of Commerce and Privacy Summit 2Dyslexic readers have disrupted network connections in the brain 2West coast log exports up, lumber exports down in second quarter of 2014 2
... with nothing more than boots, a screen and a bucket, ... percent of the biomass in Tampa Bay now say they ... that led to the development of the modern-day human immune ... a key immune system protein that is similar to but ...
... the Public University of Navarre, Antonio Gerardo Pisabarro de ... genome of the oyster mushroom. The project research team ... centres from Europe, Canada, Japan, Israel and the United ... 400 entered for the annual competition of the Joint ...
... is that DNA and genes control everything of importance in ... , Increasingly, however, scientists are realizing that among the diverse ... DNA, many interact with each other and with genes directly ... , In particular, RNA produced by the vast stretches of ...
Cached Biology News:Tiny Tampa Bay fish key to evolution of immune system 2Tiny Tampa Bay fish key to evolution of immune system 3Sequencing of the oyster mushroom genome 2Sequencing of the oyster mushroom genome 3Sequencing of the oyster mushroom genome 4Peering into the shadow world of RNA 2Peering into the shadow world of RNA 3
... ultra-compact pump available in single head (T2-04 SH) ... use in portable air and gas applications. Delivering ... well in environments where DC operation, high performance, ... critical., Offers ultra-compact size, long life, and ...
... Combining linear motor and ballscrew ... pre-engineered Cartesian solutions that include ... management, and motors., , ... Pass through high-flex cabling for ...
... as building blocks, Parker can create ... solutions that are ideal for pick-and-place ... ,system, Parker can also integrate pneumatic ... and ,guarding., Standard or custom ...
Normal Hamster Serum...
Biology Products: