Navigation Links
FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
Date:2/21/2008

Investigational antiplatelet agent submitted for treatment of patients with

acute coronary syndrome being managed with percutaneous coronary

intervention

TOKYO and INDIANAPOLIS, Feb. 21 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) accepted and designated Priority Review for the New Drug Application for prasugrel, for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI). The NDA for prasugrel was submitted to the agency on Dec. 26, 2007.

A priority designation by the FDA sets the PDUFA (Prescription Drug User Fee Act) goal date. The PDUFA goal for priority applications is to have an action provided for 90 percent of applications within six months. FDA can take three different actions - approved, approvable with further discussion, or not approved.

"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.

"If approved, prasugrel will provide physicians and acute coronary syndrome patients an alternative medicine that may further help reduce the risk of heart attacks," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Ltd.

About prasugrel

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE:

SOURCE Eli Lilly and Company
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
2. Chinese SFDA Grants Immtech Fast Track Status
3. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
4. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
5. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
6. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
7. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
8. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
9. ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
10. GlaxoSmithKline Accelerates Review of Exelixis XL880
11. Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/23/2014)... , Sept. 23, 2014 EnzymeBioSystems (OTCBB: ... along with the process of evaluating an enzyme ... in fighting tumors. In an effort to evaluate this ... with various contract research organizations to enlist their ... the use of an antitumor natural product called ...
(Date:9/23/2014)... Pa. , Sept. 23, 2014 The Pennsylvania ... drugs Sat., Sept. 27, as part of National Prescription ... no questions asked. Take-Back Day is a ... Enforcement Administration (DEA), aimed at encouraging the public to ... are prone to abuse and theft. From ...
(Date:9/23/2014)... , September 23, 2014 ... related disorders and increasing number of foreign and domestic ... probiotic in India   ... of the most high growth potential markets worldwide due ... consumers especially among the youth, changing food consumption patterns, ...
Breaking Medicine Technology:EnzymeBioSystems Announces Progress with an Enzyme Compound 2India Probiotic Market Pegged to Grow at Around 20% by 2019, Says TechSci Research 2India Probiotic Market Pegged to Grow at Around 20% by 2019, Says TechSci Research 3
... LAKE, N.J., Nov. 9 Par Pharmaceutical Companies, Inc. ... extended the expiration date and increased the purchase price ... in which Par is offering to purchase, for cash, ... approximately 82.7%, of its outstanding 2.875% Senior Subordinated Convertible ...
... , NEW YORK, Nov. 9 MISSION Skincare®, the ... soccer professional Mia Hamm, and other world class athletes, ... beauty aisle of more than 5,000 CVS/pharmacy locations across ... face, body and sun care products, MISSION and CVS/pharmacy ...
Cached Medicine Technology:Par Pharmaceutical Announces Extension and Increase in Maximum Purchase Price for 'Modified Dutch Auction' Tender Offer to Purchase up to $65,000,000 Aggregate Principal Amount of its Currently Outstanding 2.875% Senior Subordinated Convertible Note 2Par Pharmaceutical Announces Extension and Increase in Maximum Purchase Price for 'Modified Dutch Auction' Tender Offer to Purchase up to $65,000,000 Aggregate Principal Amount of its Currently Outstanding 2.875% Senior Subordinated Convertible Note 3Glamour Magazine Woman of the Year and MISSION Skincare Co-Founder, Serena Williams, Teams Up with CVS/pharmacy to Launch National 'Active Lifestyle Skincare Destinations' 2Glamour Magazine Woman of the Year and MISSION Skincare Co-Founder, Serena Williams, Teams Up with CVS/pharmacy to Launch National 'Active Lifestyle Skincare Destinations' 3
(Date:9/23/2014)... California (PRWEB) September 23, 2014 Mel ... everything about cultivating, growing and harvesting marijuana. He is ... in the field and he’ll be leading a special ... 10:00 am to 5:00 pm at Oaksterdam University ... cultivation law, botany and nomenclature, harvesting and manicuring, and ...
(Date:9/23/2014)... Florida Hospital Zephyrhills officially celebrates ... Health Center on Wednesday, September 24. With more ... designed center offers a new level of personalized ... Women’s Health Center offers comprehensive women’s services including ... delivery through The Baby Place®, and breast care ...
(Date:9/23/2014)... Advisory , NIH TO CONVENE PATHWAYS TO PREVENTION WORKSHOP: ... , WHAT: , The National Institutes of ... assess the available scientific evidence on the long-term effectiveness ... Participants will be among the nation,s top experts in ... the country, as well as key NIH scientists who ...
(Date:9/23/2014)... From first-hand experience, Matthew O'Farrell knows all about ... can be treated. , A medically retired Army veteran, ... platoon sustained multiple attacks resulting in five casualties. After ... PTSD and honorably discharged from the Army. , “I ... myself from my friends and family,” recalled O’Farrell, who ...
(Date:9/23/2014)... 2014 Dr. Connie Casad has announced that ... new office space at 12200 Park Central Drive, Suite 200, ... will be Park Cities Aesthetics, Optimal Health and Wellness, her ... her move, Dr. Casad said, “The patients’ comfort and satisfaction ... we want them to always feel like their needs are ...
Breaking Medicine News(10 mins):Health News:Special Elective Course Added to Oaksterdam University Schedule; Unique Opportunity to Learn From the “Godfather of Cannabis” Mel Frank on September 27, 2014 2Health News:Florida Hospital Zephyrhills Celebrates Grand Opening of Women’s Health Center 2Health News:Florida Hospital Zephyrhills Celebrates Grand Opening of Women’s Health Center 3Health News:NIH Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain 2Health News:NIH Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain 3Health News:Virtual Reality software to help treat PTSD 2Health News:Virtual Reality software to help treat PTSD 3Health News:Dr. Connie Casad Moving to New Office Location 2
... with improved survival odds, , SUNDAY, June 21 (HealthDay News) ... are more likely to survive these days than they would ... doctors are trying to puzzle out why heart attacks have ... doing right, and how to keep that trend headed in ...
... Implantable Cardioverter Defibrillator (ICD) have an ongoing risk of ... driving a car. Driving restrictions are imposed making ... consensus statement with recommendations for drivers with ICD,s was ... meeting, in Berlin, Germany on Sunday 21 June. ...
... approach would have the tremendous advantages of enhancing patient ... health staff to focus on medical emergencies," urged Professor ... and official spokesperson of the European Society of Cardiology ... advantage of being more cost effective for health care ...
... devastating to frail elderly and disabled Ohioans , ... Nursing Care Coalition, consisting of the three organizations representing ... than 80,000 frail elderly and disabled Ohioans, today expressed ... announced late Friday. , , "While we respect ...
... makes children fat , FRIDAY, June 19 (HealthDay News) ... fat, nor does living near a supermarket stocked with ... shows. , The study by Indiana University-Purdue University Indianapolis ... 60,000 children aged 3 to 18. They compared the ...
... that men shouldn,t take them with just this in mind ... such as aspirin and ibuprofen might help men avoid prostate ... caution men not to self-dose or to take more than ... can result. , "Our data suggest if men are taking ...
Cached Medicine News:Health News:Heart Attacks Less Often Fatal Today 2Health News:Heart Attacks Less Often Fatal Today 3Health News:Implanted defibrillators: New recommendations for drivers with ICDs 2Health News:EUROPACE raises remote monitoring profile 2Health News:EUROPACE raises remote monitoring profile 3Health News:Does Location Affect Kids' Weight? 2Health News:Painkillers May Be Good for the Prostate 2Health News:Painkillers May Be Good for the Prostate 3
... 210, Carl Zeiss has created a surgical microscope ... for ophthalmic surgery. Its wide range of uses ... and it offers new functions to improve depth ... integrated assistant's microscope the OPMI VISU 210 is ...
Blood grouping tubes are available in two formulations, ACD-A, ACD-B or with a CPDA solution. Blood grouping tubes are for blood grouping determinations and also for cell preservation....
MONOJECT Brown Stopper...
BD Vacutainer® PST™ Tubes contain spray-coated lithium heparin and a gel for plasma separation. They are used for plasma determinations in chemistry....
Medicine Products: