Navigation Links
Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDA's BYETTA(R) (Exenatide) Injection Update
Date:11/2/2009

SAN DIEGO and INDIANAPOLIS, Nov. 2, 2009 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection.

"The FDA update issued today aligns with the BYETTA label approved last week. The current label reflects our understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "Post-marketing reports of serious changes in renal function have been rare and usually complicated by other factors that could have contributed to the kidney problems. It is also important to note that diabetes is the leading cause of kidney failure. Information about use of BYETTA in patients with impaired renal function was included in the initial product label in 2005 and was updated in 2007. We remain committed to working closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products."

On October 30, the FDA approved an expanded indication for BYETTA as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. In addition to the monotherapy indication, the FDA approved changes to the BYETTA Prescribing Information to incorporate updated safety information. The new label expands u
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Amylin Pharmaceuticals Reports Third Quarter Financial Results
2. Amylin Pharmaceuticals Highlights New Data Supporting Therapeutic Potential of Obesity Pipeline at Obesity 2009
3. Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly
4. Amylin Pharmaceuticals to Present Novel Data on Promising Obesity Pipeline at 2008 Annual Scientific Meeting of The Obesity Society
5. Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity
6. Quark Pharmaceuticals to Present Data on its siRNA Therapeutic Programs in Kidney and Lung Diseases
7. Warner Chilcott Completes Acquisition of P&Gs Global Branded Prescription Pharmaceuticals Business
8. NeoStem Acquires China Biopharmaceuticals Holdings, Inc.; Obtains Controlling Interest in Profitable Leading Chinese Pharmaceutical Company
9. Cumberland Pharmaceuticals and Phebra Pty Ltd. Sign Exclusive Agreement for Commercialization of Caldolor(R) in Australia and New Zealand
10. China Biopharmaceuticals Holdings, Inc. Shareholders Overwhelmingly Support Merger with NeoStem, Inc., a NYSE AMEX Listed Company Trading Under Symbol NBS
11. Endo Pharmaceuticals Reports Third Quarter 2009 Financial Results and Increases Full-Year Financial Guidance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... , Dec. 17, 2014  Beamz Interactive, ... interactive music products, today announced that it has ... leading manufacturer and supplier of innovative prosthetic, orthotic ... As part of the agreement, RSL Steeper will ... solution specifically configured for use within UK residential ...
(Date:12/17/2014)... ANGELES , Dec. 17, 2014  ImmunoCellular ... the US Patent and Trademark Office (USPTO) has ... ICT-107, a dendritic cell-based immunotherapeutic vaccine targeting six ... The claims of US Patent No. 8,871,211, which ... neural cancer by administering a dendritic cell composition ...
(Date:12/17/2014)... Mass. , Dec. 17, 2014  RXi ... biotechnology company focused on discovering, developing and commercializing ... RNA-targeted technologies, today announced completion of enrollment in its ... from the 3-month observations confirmed the 1-month findings ... Logo - http://photos.prnewswire.com/prnh/20130917/NE80755LOGO ...
Breaking Medicine Technology:Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 3ImmunoCellular Therapeutics Announces Issuance of Key Patent For ICT-107 Cancer Vaccine 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 4RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 5
... NEW YORK, March 20, 2012  Faruqi & Faruqi, ... investigating potential securities fraud at ZELTIQ Aesthetics, Inc. ... (Logo: http://photos.prnewswire.com/prnh/20120119/MM38856LOGO  ) Faruqi ... misled investors by failing to disclose material information ...
... WASHINGTON, March 20, 2012  At a public event ... Fight AIDS, Tuberculosis and Malaria and Friends of ... spotlighted the contributions of public-private partnerships to the ... delivery, to supplying much-needed resources, to mobilizing consumer ...
Cached Medicine Technology:Faruqi & Faruqi, LLP Announces Investigation of ZELTIQ Aesthetics, Inc. 2Global Fund Celebrates Efforts of Partners Chevron, The Coca-Cola Company, (RED) and PEPFAR at Capitol Hill Event 2Global Fund Celebrates Efforts of Partners Chevron, The Coca-Cola Company, (RED) and PEPFAR at Capitol Hill Event 3Global Fund Celebrates Efforts of Partners Chevron, The Coca-Cola Company, (RED) and PEPFAR at Capitol Hill Event 4
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... and vision assessments provided by InfantSEE(R) ProgramCHARLESTON, W.Va., ... of children with eye and vision problems across ... appointments to no-cost, comprehensive eye and vision assessments ... age through InfantSEE(R). InfantSEE(R), a public health program ...
... New York, N.Y. April 28, 2009 Peripheral arterial disease ... plaque and blood supply to the legs is reduced, affects eight ... because it can limit the ability to walk and exercise, it ... increases the chance of having a heart attack or stroke. Coronary ...
... text to speech instantly converts Word, PDF, PowerPoint, Excel and Web ... ... NJ (PRWEB) April 28, 2009 -- iSpeech.org, text to speech software ... to anyone using the Box.net platform. The integration allows Box customers ...
... Health Care ReformWASHINGTON, April 28 Private-sector strategies ... an essential component of comprehensive health care reform, ... AHIP hosted a press conference today to highlight ... to reward quality and spur improvement."There is widespread ...
... membership organizations today released Guidelines for Patient Centered ... the American Academy of Family Physicians (AAFP), the ... of Physicians (ACP) and the American Osteopathic Association ... pediatrician, family physician, internist and osteopathic physician members ...
... studies have shown that depression is associated with an increased ... clear. , Now, researchers at Rush University Medical Center have ... fat, the kind of fat packed between internal organs at ... risk of cardiovascular disease and diabetes. , The study is ...
Cached Medicine News:Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 2Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 3Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 4Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 5Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 6Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 7Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 8Health News:Arterial disease of the leg frequently overlooked in patients with heart disease 2Health News:iSpeech.org Makes Box.net Talk Aloud 2Health News:New Health Plan Payment Models Are Improving Patient Quality and Safety 2Health News:New Health Plan Payment Models Are Improving Patient Quality and Safety 3Health News:New Health Plan Payment Models Are Improving Patient Quality and Safety 4Health News:Guidelines for medical home demonstrations released by major physician groups 2Health News:Guidelines for medical home demonstrations released by major physician groups 3Health News:Depression linked with accumulation of visceral fat 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 ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: