Navigation Links
Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)
Date:7/2/2009

PALATINE, Ill. and BRISTOL, Tenn., July 2 /PRNewswire-FirstCall/ -- Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090702/DC41417LOGO-a )

(Logo: http://www.newscom.com/cgi-bin/prnh/20090702/DC41417LOGO-b )

The Complete Response Letter raises issues regarding the potential abuse deterrent benefits of Acurox(R). Acura and King are currently evaluating the FDA's Complete Response Letter, and at this stage believe they can respond to the issues raised without conducting any additional studies. The Companies plan to meet with the FDA following submission of their response.

About Acurox Tablets

Acurox is a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate-to-severe pain. Acurox utilizes Acura's proprietary Aversion Technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of di
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
2. Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
3. SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
4. Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)
5. Cepheid Receives Grant to Develop Ten-Color Real-Time PCR Detection Technology for Use in the GeneXpert(R) System
6. DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD
7. Malaria Vaccine Developer, Sanaria Inc., Receives 2009 Vaccine Industry Excellence Award for Best Early-Stage Vaccine Biotech
8. NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
9. AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria
10. Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System
11. Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... FLINT, Mich. , Dec. 24, 2014  Diplomat ... largest independent specialty pharmacy, is proud to announce ... and quality at Diplomat, will take office as the ... 2015. The formal induction ceremony will take place Feb. ... which will be held at the Renaissance Center in ...
(Date:12/24/2014)... , Dec. 23, 2014 PuraMed BioScience®, ... of over-the-counter (OTC) medicinal and healthcare products, announced it ... MigraPure® H, a hemp-based, advanced headache relief product, for ... in Colorado , Washington ... With the MigraPure H Advanced headache relief ...
(Date:12/24/2014)... -- ResMed (NYSE: RMD ) today announced its ... device manufacturer BMC Medical Co., Ltd. The ... below infringe ResMed,s patents, and entered an order prohibiting BMC ... the United States : , iVolve nasal ... nasal pillows mask , iVolve full face mask ...
Breaking Medicine Technology:Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 2Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 3PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 3ResMed Wins Patent Infringement Lawsuit Against Chinese Manufacturer BMC Medical 2
... ISELIN, N.J. , April 2 Pharmos Corporation (Pink ... Phase 2b trial and the status of financing operations. Dextofisopam ... 4, 2009, Pharmos modified the size of the Dextofisopam Phase ... minimum 300 patient trial. The trial is now essentially fully ...
... J. Fox Foundation for Parkinson,s Research announced that ... total funding available under three Critical Challenges research ... the most difficult hurdles standing in the way ... opportunities focus research efforts on key priority areas ...
Cached Medicine Technology:Pharmos Issues Business Update on Dextofisopam Trial and Financing 2Michael J. Fox Foundation Commits up to $6.5 Million in Funding for Critical Challenges in Parkinson's Disease 2Michael J. Fox Foundation Commits up to $6.5 Million in Funding for Critical Challenges in Parkinson's Disease 3
(Date:12/26/2014)... December 26, 2014 India Network Foundation, ... in the USA, announced today a new version of ... in choosing the right plan for their visiting parents. ... out of the selection process when choosing an insurance ... group with only a few clicks. Many elderly Asian ...
(Date:12/26/2014)... DW-InductionHeating.com (DaWei Induction Heating Co.) is a comprehensive ... and marketing of a series of induction heating equipment. ... series of induction brazing equipments . , According ... brazing refers to the joining of two or ... The manager says that there are fundamental differences in ...
(Date:12/25/2014)... The microscopy market is estimated to ... $5,756.0 million by 2019. Optical microscopy is the ... microscopes product segment is expected to show the ... focus on nanotechnology, technological advancements, and increasing federal ... , Get Full Copy of Report @ ...
(Date:12/25/2014)... The click strand woven bamboo flooring ... Today, the business announces a click strand woven ... 30, 2015. , Click strand woven bamboo flooring ... a well-known brand in the bamboo industry. It ... reliable bamboo flooring supplier. , “We are happy ...
(Date:12/25/2014)... TX (PRWEB) December 26, 2014 The ... to 2023” focuses on the current treatment landscape, unmet ... cancer market. TS-1 is an anti-cancer drug which is ... orally and is also used for treating gastric cancer ... and otastat potassium. The drug was first approved in ...
Breaking Medicine News(10 mins):Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 2Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 3Health News:Induction Brazing Equipment Series From DaWei Induction Heating Co., A Reliable Supplier Of Induction Heating Equipment 2Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 2Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 3Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 4Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:TS-1 Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:TS-1 Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3
... a,renegade internet radio broadcaster and production company promoter, but ... particularly those with,disabilities - not exactly what you,d expect ... with the Hard Rock Cafe at Station Square,Lawless and ... planned,Pittsburgh,s first annual Rock for Autism on June 11, ...
... In between clients in his,Northfield, Illinois office, Jack Cox ... his business -- people seeking online therapy., Cox ... to his,traditional practice, recently began offering online therapy through,Psychology.com., ... are hesitant to visit me, or,any other therapist, in ...
... Sports or Play, CARLSBAD, Calif., May 13 ... of custom-fitted arch supports and,natural sponge rubber cushions, announced ... supports designed specifically for children ages 6 and older.,Two ... now,currently available at participating Good Feet Stores nationwide., ...
... CLARA, Calif., FURSTENFELDBRUCK, Germany and YOKOHAMA CITY,Japan, ... real-time,compression technology company, Schleifring und Apparatebau GmbH, ... medical and defense markets,and Tokyo Electron Device ... boards, today announced an agreement for the ...
... of Health Affairs reports on the first randomized trial ... expect from chronic disease management programs that serve low-income ... Medicaid leaders struggling to meet the needs of individuals ... management efforts, even among relatively low-risk patients, may be ...
... ... Quality Act (CEQA)., LOS ANGELES, May 12 ... expansion of its,Holy Cross Medical Center even as Superior Court Judge ... significantly flawed.,The groundbreaking ceremony held today appears to be an attempt ...
Cached Medicine News:Health News:Rockin' Out for Autism in Pittsburgh 2Health News:Psychology.com Seeing Growing Acceptance of Online Therapy 2Health News:Good Feet Announces New Arch Support Product Line for Children Ages 6 and Older 2Health News:Samplify Systems Announces Availability of Compression for Computed Tomography; Integrated Slip-Ring Solution to be Jointly Developed with Schleifring und Apparatebau and Tokyo Electron Device Ltd. 2Health News:Samplify Systems Announces Availability of Compression for Computed Tomography; Integrated Slip-Ring Solution to be Jointly Developed with Schleifring und Apparatebau and Tokyo Electron Device Ltd. 3Health News:Samplify Systems Announces Availability of Compression for Computed Tomography; Integrated Slip-Ring Solution to be Jointly Developed with Schleifring und Apparatebau and Tokyo Electron Device Ltd. 4Health News:Chronic disease management: Does it improve health and save money? 2Health News:Providence Holy Cross Medical Center Ignores Community, Environmental Concerns With Planned Expansion of Mission Hills Facility 2
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
Medicine Products: