Navigation Links
Lilly and Avid Receive Complete Response Letter from FDA for Amyvid™ (florbetapir F 18 injection)
Date:3/18/2011

INDIANAPOLIS and PHILADELPHIA, March 18, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a complete response letter from the U.S. Food and Drug Administration (FDA) for their New Drug Application (NDA) for Amyvid™ (florbetapir F 18 injection), a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients.

The complete response was primarily focused on the need to establish a reader training program for market implementation that helps to ensure reader accuracy and consistency of interpretations of existing Amyvid scans.

"Lilly and Avid have been engaged in an active and ongoing dialogue with the FDA," said Wei-Li Shao, Lilly brand director for Amyvid. "We remain confident in the data submission package for Amyvid."

Since questions on the reader training program were raised by FDA reviewers late last year, Lilly and Avid have been working to address these questions and will continue to do so in an ongoing dialogue with the FDA.

About Amyvid™ (florbetapir F 18 injection)

Amyvid is a molecular imaging agent under investigation for PET imaging of beta-amyloid plaque in the brain.  Clinical studies for Amyvid are being conducted in the E.U., North and South America, Australia and Asia.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. 
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
3. Lilly and Glenmark Pharmaceuticals Announce License Agreement
4. Lilly Receives NCQA Design Certification for Depression Care Management Program
5. JDRF and Lilly Partner to Fund Research to Identify Beta Cell Biomarkers
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
8. Lilly and Transition Therapeutics Announce Licensing and Collaboration Agreement
9. Lilly Launches Its First Phase III Trial for Treatment of Alzheimers Disease
10. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
11. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... BURLINGTON, Mass. , July 10, 2014 /PRNewswire/ ... three-quarters of surveyed infectious disease (ID) specialists are ... Medicines Company,s Orbactiv (oritavancin) for use as OPAT, ... to prescribe these agents to their hospital inpatients. ... percent) of OPAT patients are initiated on OPAT ...
(Date:1/15/2014)... N.Y. , Jan. 15, 2014 Sono-Tek Corporation (OTC ... months ended November 30, 2013, compared to sales of $2,202,000 ... 20%. Once again, this quarter has also shown growth over ... the first quarter of this fiscal year. Markets that experienced ...
(Date:1/15/2014)... , Jan. 15, 2014 As health officials across the ... select Meijer pharmacies in Michigan will ... eligible patients, enabling Meijer pharmacists to administer tests and, in ... by a physician participating in the study. The ...
Breaking Medicine Technology:Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3Sono-Tek Announces Third Quarter Results 2Sono-Tek Announces Third Quarter Results 3Sono-Tek Announces Third Quarter Results 4Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 2Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 3
... ANNAPOLIS, Md., April 28 /PRNewswire-FirstCall/ -- PharmAthene, ... company developing medical countermeasures against biological and chemical threats, ... call for investors on Wednesday, April 29th beginning at ... rPA anthrax vaccine program. The dial-in number within the ...
... Urological Association Annual Meeting --SEATTLE and CHICAGO, April ... DNDN ) today presented preclinical data demonstrating ... molecule, which targets TRPM8 (a transmembrane cation channel ... D-3263 demonstrated the ability to reduce BPH alone ...
Cached Medicine Technology:PharmAthene to Host a Conference Call and Webcast on Wednesday, April 29th at 4:30 PM to Provide an Update on the SparVax(TM) rPA Anthrax Vaccine Program 2Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia 2Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia 3Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia 4
(Date:7/12/2014)... 2014 In this cognitive ... assessment and training’ is defined as solution ... or enhance cognitive functions. These solutions are ... dementia screening, clinical trials, driver’s safety, rehabilitation, ... assessment, brain training, and employers’ assessment and ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 The Security ... in 2013 to $3,376.6 million by 2019, at an ... and 2019. The challenges to counter the increasing number ... existence of outdated cyber defense systems in organizations are ... innovating and remodeling their existing architecture to develop better ...
(Date:7/12/2014)... New York (PRWEB) July 12, 2014 ... damage allegations continue to move forward in the ... Eastern District of Pennsylvania, Bernstein Liebhard LLP reports. ... U.S. District Judge Lawrence F. Stengel has ordered ... other things, Judge Stengel found that the witness’s ...
(Date:7/12/2014)... (HealthDay News) -- If you make exercise fun, you,ll eat ... experiment, 56 adults were led on a 1.4-mile walk and ... a scenic walk. The participants were given lunch after the ... outing ate 35 percent more chocolate pudding for dessert than ... In another experiment, 46 adults were given mid-afternoon snacks after ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 "The second toes ... uncomfortable and painful to wear shoes," said an inventor from ... sock that prevents this from happening. , He then created ... way to prevent the second and big toes from overlapping. ... while wearing shoes. Ergonomic and easy to use, it's ideal ...
Breaking Medicine News(10 mins):Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 2Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 3Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 4Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 5Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 4Health News:Tylenol Lawsuit News: U.S. District Judge Overseeing Federal Tylenol Liver Damage Litigation Orders Deposition of Former McNeil President, Bernstein Liebhard LLP Reports 2Health News:Tylenol Lawsuit News: U.S. District Judge Overseeing Federal Tylenol Liver Damage Litigation Orders Deposition of Former McNeil President, Bernstein Liebhard LLP Reports 3Health News:Tylenol Lawsuit News: U.S. District Judge Overseeing Federal Tylenol Liver Damage Litigation Orders Deposition of Former McNeil President, Bernstein Liebhard LLP Reports 4Health News:Make Exercise Fun, Eat Less Afterwards 2
... you think. Low doses of radiation have been found to ... not uncommon for children who suffer from medulloblastoma to undergo ... in affecting IQ and reading skills of younger children rather ... has been found that the greatest rates of decline in ...
... has claimed at least 20 lives in the past two ... is already present in the neighboring Indian state of UP ... caused 10 deaths each in the townships of Tikapur and ... over 80 patients were undergoing treatment in various hospitals and ...
... that the loss of a gene called p63 accelerates the ... present in many organisms, including humans // . Drawing parallels ... is likely to play a fundamental biological role in aging-related ... researchers had devised a system for eliminating it from adult ...
... prevent infections in older people living at home, report ... segment of the supplement-taking population. //, ,Studies in ... supplements, elderly people in nursing homes were 20 per ... had fewer colds over the study period than a ...
... at Jefferson Medical College had discovered the existence of ... biomarker for conditions that lead to heart failures. Based ... a blood test to predict the onset of heart ... previously showed that an enzyme called GRK2 or beta-adrenergic ...
... become nearly twice as prevalent in high schools in the ... middle school students admit that drugs are used, kept or ... where drugs are widely available are three times more likely ... alcohol than their peers who attend drug-free schools., ,Availability ...
Cached Medicine News:Health News:Latest Research Shows That Multivitamins Might Not Prevent Infections In All Elderly 2Health News:Blood Test To Predict Heart Failures 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: