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:7/2/2015)... 2015  New product launches are critical events for ... educating thought leaders about new products, Medical Affairs is ... well a new therapy performs at launch. ... consulting leader Best Practices, LLC, critical aspects of launch ... are early stage thought leader (TL) interaction, successful TL ...
(Date:7/2/2015)... OXFORD, England , July 2, 2015 ... commonly known as ,Friendly Aedes aegypti , ... of Juazeiro, Brazil by 95%, ...      (Logo: http://photos.prnewswire.com/prnh/20150630/227348LOGO) , The ... of a trial of Oxitec,s genetically engineered mosquitoes. The ...
(Date:7/2/2015)... June 26, 2015 Research and ... "Vitamin D Market by Analog, Application, End-User & by Region ... their offering. This market is projected to reach ... D in different applications and rising opportunities in countries such ... , Italy , and Brazil ...
Breaking Medicine Technology:Medical Affairs Role in Thought Leader Education is Key Success Factor for New Product Launches in the Pharmaceutical Industry 2Oxitec Mosquito Works to Control Aedes aegypti in Dengue Hotspot 2Oxitec Mosquito Works to Control Aedes aegypti in Dengue Hotspot 3Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 2Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 3
... & White Healthcare today teleconferenced one of the world,s ... aortic aneurysm to conference attendees in Sao Paolo, Brazil. ... is one of the globe,s largest vascular surgery events ... use of an endograft device called a repositionable endoprosthesis. ...
... 21, 2011 Caliper Life Sciences, Inc. (NASDAQ: ... President and CEO, will present at the 36th Annual ... 2, 2011 at 10:40 a.m. ET. ... at http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=CALP&item_id=3909124 or by visiting Caliper,s website ...
Cached Medicine Technology:Scott & White Healthcare Broadcasts Live Surgery to Sao Paolo, Brazil 2
(Date:7/4/2015)... ... ... gains access to someone’s email account, it can lead to all sorts of trouble, both ... issued a scam alert about a social engineering scam which cons a target into ... the hacker. All they have to do is click for a password reset and ...
(Date:7/3/2015)... ... July 03, 2015 , ... ... lineup for its 2015 Annual Conference , the premiere continuing education ... the Renaissance Orlando at SeaWorld in Orlando, Florida. Speakers include the leading ...
(Date:7/3/2015)... ... July 03, 2015 , ... ... place on June 25, 2015 at 1:00pm. The Association welcomed speaker C. Daniel ... to injured bicyclists and practical points of investigating these types of cases. , ...
(Date:7/3/2015)... ... ... Selfie on a Stick ” was featured on NewsWatch as part of its monthly ... Forstrom, a technology expert and special reporter for NewsWatch, conducted the review and shared ... smartphone has an incredibly powerful camera built into it. And when someone is traveling ...
(Date:7/2/2015)... ... , ... sweetFrog Enterprises, LLC. is pleased to announce the opening of its newest location in ... State. The premium frozen yogurt chain was listed as #22 on the Inc. 500 list ... Village at Bachman Lake, is located at:, 3701 W. Northwest Highway, STE 430, Dallas, TX ...
Breaking Medicine News(10 mins):Health News:New FTC Scam Alert Shows Latest Example of Social Engineering Dangers 2Health News:New FTC Scam Alert Shows Latest Example of Social Engineering Dangers 3Health News:New FTC Scam Alert Shows Latest Example of Social Engineering Dangers 4Health News:RNS Announces Sessions and Speaker Lineup for the 2015 Annual Conference of the Rheumatology Nurses Society 2Health News:RNS Announces Sessions and Speaker Lineup for the 2015 Annual Conference of the Rheumatology Nurses Society 3Health News:Attorney from William Mattar Leads Discussion on Bicycle Accidents 2Health News:Learn How to Take Selfies like Kendall Jenner 2Health News:sweetFrog Opens 18th Location in the Lone Star State 2
... 37 Others in Screening for,Life-Threatening, Genetic Disease, WASHINGTON, ... other states and the District of Columbia in,requiring that ... In addition, the Nevada Department of Health has ... will be implemented when,state lawmakers set an implementation date., ...
... 2008 High cholesterol levels are considered to be ... many cholesterol lowering drugs have been developed by pharmaceutical ... statins, has been found to reduce the incidence of ... , In a recent paper published in the ...
... no one to turn to for emotional support other than ... when suffering from cancer. However, according to new research, the ... relationship. , Previous research has shown that many Swedish ... about the disease to few other people, if any. For ...
... Ohio An oil made of natural fatty acids that ... be paired with hormones or other substances to prevent health ... suggests. , Conjugated linoleic acid (CLA), a compound naturally found ... in some studies in humans. But a recent study in ...
... Content, Social Media and More to Promote JOHNSON,S(R) Melt ... ... April 9, 2008 JOHNSON,S(R), the,skincare expert, today announced the ... to promote its award-winning Melt,Away Stress line of skin care ...
... Aida,Pharmaceuticals, Inc. (OTC Bulletin Board: AIDA) ... the Jiangsu Province, the Jiangsu,Institute of Microbiology ... new,wide-spectrum antibiotic, Wetimicin, in the People,s Republic ... of amino-glycoside family of,antibiotics and is being ...
Cached Medicine News:Health News:Three New States Join Efforts to Screen Newborns for Cystic Fibrosis 2Health News:Dietary oil may need help in avoiding any side effects of weight loss 2Health News:Dietary oil may need help in avoiding any side effects of weight loss 3Health News:JOHNSON'S(R) Launches New Online Campaign Tapping Glam Media to Reach Young Women 2Health News:JOHNSON'S(R) Launches New Online Campaign Tapping Glam Media to Reach Young Women 3Health News:JOHNSON'S(R) Launches New Online Campaign Tapping Glam Media to Reach Young Women 4Health News:JOHNSON'S(R) Launches New Online Campaign Tapping Glam Media to Reach Young Women 5Health News:Aida Pharmaceuticals, Inc. Announces New Antibiotic Drug Under Development 2
... T helps provide protection to the exposed airway ... extremely lightweight making it ideal for active young ... rate of heat and moisture recovery, it ensures ... HMEs and filters have ISO standard tapered ends ...
circuitGuard™ Products are available in filter or filter/HME styles., ,High quality air cushion anesthesia masks may be packaged with any circuitGuard™ product....
... 1991 Intersurgical Incorporated manufactures ... heat and moisture exchangers, ... products, hand-held nebulizers and ... accessories and connectors for ...
... Intersurgical Incorporated manufactures high ... and moisture exchangers, ventilator ... hand-held nebulizers and an ... and connectors for anesthesia ...
Medicine Products: