Navigation Links
Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™
Date:10/19/2010

SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Oct. 19 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

In the complete response letter the FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol will be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. This letter did not cite any manufacturing processes referenced in the FDA's March 15 complete response letter. REMS and product labeling discussions will continue following submission of the additional data.

The companies' goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.

"We are committed to working closely with the FDA to resolve the issues raised in the complete response letter so that BYDUREON can be approved, and we can make this important treatment available to patients with type 2 diabetes as quickly as possible," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "We remain confident in BYDUREON based on the extensive exenatide d
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7

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:6/19/2013)... , 19. Juni 2013 /PRNewswire/ ... dass mit der Entwicklung von SCS ... Schritt in der Beschichtung mit Parylene ... Vorteile von biokompatiblem Parylene mit antimikrobiellen ... Beseitigung schädlicher Mikroorganismen auf beschichteten medizinischen ...
(Date:6/19/2013)... -- It may seem like an odd pairing: an oral growth ... were two of the most talked about topics at ENDO ... Expo that just convened in San Francisco ... of the top internal medicine experts in the world is ... can not only save lives, but help people feel and ...
(Date:6/18/2013)... MILAN , June 19, 2013 ... in fluctuating Parkinson,s disease (PD) patients as add-on ... clinically important improvement in motor symptoms in fluctuating ...   Newron Pharmaceuticals S.p.A. ("Newron"), a ... and pain therapies, and its partner Zambon S.p.A., ...
Breaking Medicine Technology:Specialty Coating Systems gibt die Einführung einer neuen antimikrobiellen Parylene-Technologie bekannt 2"Miracle" Breast Cancer Drug and "Youth Hormone" Pill Steal Show at Prestigious Endocrine Society Conference 2"Miracle" Breast Cancer Drug and "Youth Hormone" Pill Steal Show at Prestigious Endocrine Society Conference 3"Miracle" Breast Cancer Drug and "Youth Hormone" Pill Steal Show at Prestigious Endocrine Society Conference 4Safinamide Phase III Study Results Presented at 2013 MDS Meeting 2Safinamide Phase III Study Results Presented at 2013 MDS Meeting 3Safinamide Phase III Study Results Presented at 2013 MDS Meeting 4Safinamide Phase III Study Results Presented at 2013 MDS Meeting 5Safinamide Phase III Study Results Presented at 2013 MDS Meeting 6
... Alabama Medicaid and the State of Alabama are ... build the infrastructure for a statewide health information exchange ... controlling costs. (Logo: http://photos.prnewswire.com/prnh/20090507/NY12658LOGO) The ... by a diverse group of stakeholders into functional, user-friendly ...
... LAS VEGAS, Nov. 11, 2011 Panasonic Healthcare Group ... formed an alliance with Cenegenics Medical Institute to implement ... disease detection and age management. Panasonic,s CardioHealth® Station continues ... that one of the best ways to reduce long-term ...
Cached Medicine Technology:Alabama Selects Thomson Reuters HIE Advantage™ for Statewide Health Information Exchange 2Alabama Selects Thomson Reuters HIE Advantage™ for Statewide Health Information Exchange 3Panasonic Unveils Relationship with Cenegenics Medical Institute Featuring CardioHealth Station 2Panasonic Unveils Relationship with Cenegenics Medical Institute Featuring CardioHealth Station 3Panasonic Unveils Relationship with Cenegenics Medical Institute Featuring CardioHealth Station 4
(Date:6/19/2013)... The reason for the popularity of the Gorilla Grow ... 4x8 flood tray inside the 5’x9’ and have a one ... addition, Gorilla Grow Tents are more like grow rooms than ... strongest grow tents on the market, Gorilla Grow Tents, have ... , Gorilla Grow Tents are made for professionals but still ...
(Date:6/19/2013)... To survive when your plane goes down on a combat mission, ... the most important item in a survival kit is not a ... Kleyne Hour Power of Water radio show, Orr stated that in ... ahead of guns or even food. , According to Orr, the ... carry on planes in Vietnam. He was the only Navy pilot ...
(Date:6/19/2013)... website HealthNewsWires.com has recently published an informative article and ... to manage and prevent the condition. , In a ... insulin resistance as a condition that impairs ... the bloodstream. Glucose, or blood sugar, is an ... of the body for normal function. The inability ...
(Date:6/19/2013)... New York,NY (PRWEB) June 19, 2013 ... company officials at SizeItUp formally announced the ... This smartly renovated van is the latest entry in ... for the year 2013. The completely redesigned 2012 Nissan ... the automobile lovers and critics alike. , Provided with ...
(Date:6/19/2013)... (PRWEB) June 19, 2013 Tornadoes and ... year. Many families who have fallen victim to these ... Engineering International Inc. has protected families and corporations ... Radius Engineering International Inc. believes in the philosophy of ... the water table, that allows people to stand up, ...
Breaking Medicine News(10 mins):Health News:Stealth Grow Tent Brand’s Popularity Rises 2Health News:Vietnam Navy Pilot Reveals to Radio Host Sharon Kleyne That He Carried Extra Water Not a Gun in Survival Kit 2Health News:Effects of Insulin Resistance and How to Increase Insulin Sensitivity Published in New Video by Health News Wire 2Health News:Rim Fitments Expert, SizeItUp Comes Up With Database Integrations For The 2012 Nissan NV 2Health News:Radius Engineering International Inc. Tornado-Resistant Storm Shelters 2
... test, experts say, , , MONDAY, Nov. 17 (HealthDay News) -- ... have asthma may not have the chronic airway disease, new ... 18 issue of the Canadian Medical Association Journal , ... that about 30 percent of those diagnosed with asthma had ...
... sunscreen, have greatest desire to tan , , MONDAY, Nov. ... can help prevent a pleasant seaside vacation from turning ... A detailed study of 88 Hawaii vacationers identified three ... behaviors, according to a report in the December issue ...
... be especially useful for blacks, other high-risk groups , , MONDAY, ... to use five genetic markers to assess whether a man ... study suggests. , If reliable, these five "single nucleotide polymorphisms" ... of any race with a family history of prostate cancer. ...
... MAYWOOD The temperature might not be the only thing plummeting ... their vitamin D levels, which can play a role in heart ... , Vitamin D deficiency results in part from ... when days are shorter and more time is spent indoors. ...
... researchers from The Miriam Hospital,s Centers for Behavioral and ... can yield better postoperative outcomes. , According to ... , previously inactive patients who became physically active after ... in quality of life than those patients who remained ...
... they stayed that way , , MONDAY, Nov. 17 (HealthDay News) ... explain why some develop dementia while others are among the ... ability well into old age. , In a preliminary study, ... over 80 have none, or very little, of the protein ...
Cached Medicine News:Health News:Nearly 1 in 3 Asthma Cases May Be Misdiagnosed 2Health News:Nearly 1 in 3 Asthma Cases May Be Misdiagnosed 3Health News:Study Singles Out Beachgoers' Skin Cancer Risk 2Health News:Study Singles Out Beachgoers' Skin Cancer Risk 3Health News:Gene Screen Might Predict Prostate Cancer 2Health News:Physical activity after bariatric surgery improves weight loss, quality of life 2Health News:Fewer Brain 'Tangles' May Mean Smarter Old Age 2Health News:Fewer Brain 'Tangles' May Mean Smarter Old Age 3
... is the world's first Windows 2000 ... system. It allows data sharing with ... compatible with Microsoft Office 2000. Data ... on the large, sharp 14.1-inch TFT ...
... Vitatron T-series is a new top-line ... of bradycardia and Atrial Fibrillation (AF). Because ... solutions for AF, the treatment of AF ... the digital technology the heart rhythm is ...
... Expandable Spinal System is intended for use ... - preloaded on its Delivery System - ... in a reduced configuration of 5 mm ... 15mm (depending on the size selected) once ...
... maximize patient comfort and deliver optimal treatment. ... feature Vacuum Pump Deflation Technology. This proprietary ... "slamming" effect commonly associated with other systems. ... comfort and security while treatment is delivered. ...
Medicine Products: