Navigation Links
Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months
Date:11/13/2009

SAN DIEGO, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.

"We remain confident in our NDA submission and will continue to work closely with the FDA toward the potential approval of intravenous acetaminophen," said Ted Schroeder, President and Chief Executive Officer of Cadence. "We are now planning for a launch early in the second quarter of 2010 and continuing to move forward with all of our commercial readiness activities, including recruitment of our sales force."

The FDA designated one of Cadence's submissions to the NDA, which contained additional clinical pharmacology data requested by the agency during the review process, as a major amendment. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide time to complete the review. The FDA is not requesting any other information at this time.

About IV Acetaminophen

IV acetaminophen is Cadence's proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products. Cadence acquired the exclusive rights to the proprietary intravenous form of acetaminophen in the United States and Canada in 2006 from Bristol-Myers Squibb Company, which markets the product as Perfalgan® in Europe and other parts of the world. IV acetaminop
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Cadence Pharmaceuticals Completes Enrollment of Pivotal Phase III Trial for Intravenous Acetaminophen Ahead of Schedule
2. Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update
3. Cadence Pharmaceuticals to Host Conference Call and Webcast to Discuss Second Quarter 2008 Financial Results and Provide a Clinical Program Update on August 7, 2008
4. Cadence Pharmaceuticals Updates Omigard(TM) Clinical Timeline
5. Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Programs Update
6. Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
7. Cadence Pharmaceuticals to Webcast October 7th Analyst Day
8. Cadence Pharmaceuticals CEO Ted Schroeder to Present at the BIOCOM Investor Conference in San Diego on October 27, 2009
9. Cadence Pharmaceuticals CEO Ted Schroeder To Present at the Oppenheimer 20th Annual Healthcare Conference in New York City on November 4, 2009
10. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
11. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... 2014 Reportlinker.com announces that a new ... catalogue: PharmaPoint: Atopic ... Analysis to 2022 http://www.reportlinker.com/p01957657/PharmaPoint-Atopic-Dermatitis---India-Drug-Forecast-and-Market-Analysis-to-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology ... India Drug Forecast and Market Analysis to ...
(Date:1/15/2014)... , Jan. 15, 2014  Zafgen, Inc., a leading ... of severely obese patients, today announced initial results ... selective inhibitor of methionine aminopeptidase 2 (MetAP2), in ... of genetic obesity.  These results showed improvements in ...
(Date:1/14/2014)... , Jan. 14, 2014 InformEx, North America,s ... of high-value chemistry, will hold the 30 th edition ... Convention Center from January 21-24. (Logo: ... from top pharmaceutical, fine chemical and specialty chemical companies will ...
Breaking Medicine Technology:PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2
(Date:4/22/2014)... influenced by low exposure to testosterone in the womb, ... men,s testosterone levels may be determined before they are ... the hormone than others is important because testosterone is ... hormone have been linked to obesity, diabetes and heart ... for producing testosterone in adults known as Leydig ...
(Date:4/22/2014)... fiction: In enemy territory, activate your cloaking device. And ... to the immune system. Now scientists at Harvard,s Wyss ... tactics to build the first DNA nanodevices that survive ... the way for smart DNA nanorobots that could use ... doctors can today; target drugs to tumors, or even ...
(Date:4/22/2014)... a clinical trial led by Dana-Farber Cancer Institute ... approved a molecularly targeted drug as second-line treatment ... standard chemotherapy has failed. , The FDA approval ... manufacturer, Lilly Oncology, of Indianapolis. A monoclonal antibody ... sold under the name Cyramza, and is the ...
(Date:4/22/2014)... the University of Toronto say a sleep disorder that ... best current predictor of brain diseases like Parkinson,s and ... not just a precursor but also a critical warning ... says associate professor and lead author Dr. John Peever. ... cent of people with RBD will develop a brain ...
(Date:4/21/2014)... Minn. Acute respiratory distress syndrome is a ... who develop the lung disorder postoperatively are at ... those who survive the syndrome may still bear ... Mayo Clinic-led study is helping physicians better identify ... preventing this dangerous and costly surgical complication. ...
Breaking Medicine News(10 mins):Health News:Cloaked DNA nanodevices survive pilot mission 2Health News:Cloaked DNA nanodevices survive pilot mission 3Health News:FDA approves first targeted drug for advanced stomach cancer 2Health News:Acute respiratory distress syndrome: Study IDs surgical patients at risk 2
... New York, NY (June 6, 2012) A clinical ... molecular therapy called vismodegib (trade name Erivedge), can dramatically ... of new ones, in patients with basal cell nevus ... sometimes hundreds or thousands, of skin cancers on each ...
... In a Phase 2 study presented at the ... Oncology (ASCO), clinical researchers from University Hospitals Case Medical ... to treat gynecologic cancers, shortening radiation treatment time from ... stereotactic body radiotherapy (SBRT), has been used on other ...
... THURSDAY, May 31 (HealthDay News) -- Live chicks and ducklings ... a salmonella outbreak that had sickened 93 people in 23 ... in an update Thursday. Eighteen people have been ... under investigation. Among the reported cases so far, illnesses surfaced ...
... , THURSDAY, May 31 (HealthDay News) -- Meat, ... associated with a fivefold increased risk of immediate gout flare-ups, ... arthritis that often first occurs in the big toe. Anecdotal ... but it hasn,t been clear whether they cause immediate attacks. ...
... , THURSDAY, May 31 (HealthDay News) -- More than ... new government report shows. "Untreated tooth decay is ... Dye, an epidemiologist at the U.S. Centers for Disease ... appears that we haven,t been able to make any ...
... Steven Reinberg HealthDay Reporter , THURSDAY, May 31 ... the United States may be infected with chronic hepatitis B ... come from countries in Asia and Africa, where regular vaccination ... "Hepatitis B is a common infection transmitted at birth or ...
Cached Medicine News:Health News:New drug found effective against rare form of basal cell skin cancer 2Health News:New drug found effective against rare form of basal cell skin cancer 3Health News:University Hospitals Case Medical Center experts present at ASCO Annual Meeting 2Health News:University Hospitals Case Medical Center experts present at ASCO Annual Meeting 3Health News:Ohio Mail-Order Hatchery Now Linked to Salmonella in 23 States 2Health News:Gout Flare-ups Rise Sharply With Certain Foods: Study 2Health News:1 in 5 Americans Has Untreated Cavities: CDC 2Health News:Hepatitis B Infection Rates in U.S. Higher Than Thought 2Health News:Hepatitis B Infection Rates in U.S. Higher Than Thought 3
Inquire...
Rapid Urease test for the presumptive identification of H. pylori in gastric mucosal biopsies...
... The QuickVue H.pylori gII test is a ... qualitative detection of IgG antibodies specific to ... whole blood. It utilizes a convenient, non-invasive, ... aid physicians in the diagnosis of H.pylori ...
... a visually read, qualitative immunochromatographic method for ... a bacterium that grows in the stomach ... and some gastric cancers. FlexSure HP, available ... serum samples, provides the physician with the ...
Medicine Products: