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

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:7/10/2014)... NEWPORT NEWS, Virginia , 11. ... führender Hersteller von Kameras für die ... Brust (MBI/BSGI), hat heute die CE-Zulassung ... Mit dem CE-Zeichen kann Dilon das ... seinen Vertriebsbereich auf den Großteil der ...
(Date:7/10/2014)... 10, 2014 Yesterday, former Congressman ... device manufacturing facility. Rep. Kennedy and Dick ... facilitate cutting-edge research in neurological disease and treatment. ... health advocate, Garen Staglin , created One ... fundamental changes that will radically accelerate the development ...
(Date:7/10/2014)... , July 10, 2014   LabStyle ... Management Solution, today announced the appointment of Professor ... member of its Board of Directors. ... and business experience to LabStyle as an entrepreneur, ... legal and corporate governance expert. He currently serves ...
Breaking Medicine Technology:Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2Representative Patrick Kennedy visits Moberg's medical device facility to discuss improvement in brain injury care 2LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 2LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 3LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 4
... , , SEATTLE, Dec. 9 Omeros Corporation today ... to serve on the Company,s Board. Mr. Spiegelman has also been ... are very pleased to welcome Dan to our Board and look ... CEO of Omeros. "Dan brings a substantial depth and breadth of ...
... , WALTHAM, Mass., Dec. 9 Decision ... focusing on pharmaceutical and healthcare issues, finds that compared to ... are being used more often to treat newly diagnosed patients ... second-line patients received a TNF-alpha inhibitor versus one year ago ...
Cached Medicine Technology:Daniel K. Spiegelman Elected to Board of Directors of Omeros 2TNF-Alpha Inhibitors Are Being Used More Often To Treat Newly Diagnosed Patients With Crohn's Disease 2TNF-Alpha Inhibitors Are Being Used More Often To Treat Newly Diagnosed Patients With Crohn's Disease 3
(Date:7/12/2014)... (PRWEB) July 12, 2014 Doylestown Hospital ... a variety of men’s health questions. Paddock tackles ... to men, why women live longer than men, and ... Men's Health Made Simple featured on Doylestown Hospital’s ... a hernia at any age. If you notice pain, ...
(Date:7/12/2014)... July 12, 2014 Utah Valley Entrepreneurial ... startups, with awards being bestowed to companies in revenue, ... outstanding entrepreneur community with recognition for new ideas as ... with incoming revenue. , 25 Under 5 highlights outstanding ... that are under 5 years old. Award recipients were ...
(Date:7/12/2014)... article released by Seattle's well known plastic surgeon, Dr. Bryan ... cosmetic surgical procedures in summer months . , As ... enliven the rainy Pacific Northwest, many people are turning their ... out as much during the winter as they had planned. ... eager to look their best for their summer vacations, and ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 Wright & Schulte ... clients in Just For Men Lawsuits (case #59776/2014), announces ... consumers of reports that allege the popular hair dye, Just ... burns to their face, neck and other areas. In addition ... For Men chemical burns , the advertisements being run by ...
(Date:7/12/2014)... CA (PRWEB) July 12, 2014 ... power score of 4.1 out of 5. This ... that have been underpinning buyer negotiation power over ... procurement analyst Anna Son, “during the period, surging ... rising costs associated with new product development, have ...
Breaking Medicine News(10 mins):Health News:Ivyland Medical Center’s Dr. Brad Paddock Offers Tips for Men’s Health 2Health News:SquareHook is Recognized for UVEF 25 Businesses Under 5 Years-Watch Out 2Health News:Best Summer Cosmetic Surgeries Revealed in Article By Seattle Plastic Surgeon 2Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 2Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 3Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 4Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 2Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 3Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 4
... , , , ... (AAOS)Creates Independent Organization , , ROSEMONT, ... incorporated the American Joint Replacement Registry (AJRR), a nonprofit organization dedicated to ... this proposed option is a patient safety best practice. , ...
... Achievement shows how ,plastic, these non-embryonic cells can be, ... The mouse may be named "Tiny," but what it ... that. , According to Chinese researchers, the birth of ... cell research: Healthy, fertile animals grown using so-called pluripotent ...
... The largest single competitive NSF award in SC history , ... Science Foundation (NSF) has awarded South Carolina $20 million to establish a statewide ... of human organs. , , Lead ... said, "We are trying to build tissue and organs from the inside out, ...
... , HARRISBURG, Pa., July 23 More ... care, valued at nearly $160,000, in the second quarter of ... , , "These clinics are ... services to those who cannot afford dental care," said Harlon ...
... , , SPOKANE, Wash., ... partnership with eHealth Initiative will hold the Northwest Medical ... national and regional speakers on September 10 and 11 ... rural healthcare professionals to learn about the latest in ...
... , DULUTH, Ga., July 23 /PRNewswire/ -- Get Screened ... to NHRA -- National Hot Rod Association -- fans at selected national ... at several recent NHRA race events, provides free blood pressure ... derma-scans to the race attendees. While Get Screened America focuses on ...
Cached Medicine News:Health News:American Joint Replacement Registry Announced 2Health News:Scientists Use Adult Stem Cells to Create Healthy Mice 2Health News:Scientists Use Adult Stem Cells to Create Healthy Mice 3Health News:National Science Foundation Announces $20M Research Award to South Carolina 2Health News:National Science Foundation Announces $20M Research Award to South Carolina 3Health News:More than 1,000 Underinsured and Uninsured Individuals Receive Free Dental Care 2Health News:INHS Brings Health Information Technology Conference to Spokane 2Health News:Get Screened America Goes After The 'Silent Killers' 2
... 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 ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... 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: