Navigation Links
Bayer Announces Availability of Reformulated Liquid Leukine(R)
Date:5/19/2008

- EDTA removed from product -

WAYNE, N.J., May 19 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that a reformulation of the liquid Leukine(R) (sargramostim) 500 mcg vial has been approved by the United States Food and Drug Administration (FDA) and is now available for patients and physicians in the U.S. The new formulation does not contain EDTA (edetate disodium), which was in the product's liquid 500 mcg vial manufactured from January 2006 to January 2008.

"The reintroduction of liquid sargramostim without EDTA is welcome news to oncologists and hematologists," said Mark Heaney, MD, PhD, Associate Attending Physician, Memorial Sloan-Kettering Cancer Center, New York, NY, who has studied the biology of the receptor of this drug for more than a decade. "Sargramostim has an important role in reducing life-threatening infections and early death due to infections among older adults (> 55 years of age) with acute myelogenous leukemia (AML). Further, sargramostim is an important therapy in cancer supportive care and has a proven survival benefit in patients experiencing bone marrow transplant failure or engraftment delay."

In January 2008, Bayer withdrew the previously marketed liquid Leukine 500 mcg vial from the U.S. market in order to reformulate it to eliminate EDTA in light of an increase in spontaneous reporting of certain labeled adverse events, including syncope (fainting). The timing of increased reporting of these adverse events coincided with the change in the formulation of liquid Leukine to include EDTA in 2006. With the approval and relaunch of liquid Leukine in a non-EDTA formulation, Bayer is closing a special access program that reserved priority access to lyophilized Leukine 250 mcg vials, which do not contain EDTA, for patients with the greatest medical need. Sufficient supply of the new, non-EDTA liquid and lyophilized formulations of Leukine is now available to meet cancer care mar
'/>"/>

SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. ACT Biotech Acquires Clinical and Early Stage Oncology Portfolio Licenses From Bayer Healthcare
2. United Nations Environment Programme and Bayer Corporation Announce North American Winners of International Childrens Painting Competition
3. Bayer/Schering-Plough/Shionogis Avelox Has Advantages Over Levofloxacin in the Treatment of Community-Acquired Pneumonia
4. Bayer HealthCare Pharmaceuticals, Amerinet Extend Contrast Media Agreement
5. Bayer to Receive Two Top National Awards for Its Science Education, Science Literacy Work
6. Bayer HealthCare and Juvaris BioTherapeutics Announce Major Licensing Agreement
7. 60 Minutes to Report on Dangers of Trasylol: Cory Watson Crowder & DeGaris Involved in Litigation Against Pharmaceutical Giant Bayer AG
8. Bayer Establishes US Special Access Program for Leukine(R) While Replacing Current Liquid Formulation
9. Bayer Corporation Renames Its U.S. Foundation, Refocuses Charitable Giving Areas
10. New Bayer, United Nations Partnership Brings International Environment and Art Competition to Local Elementary and Middle Schools
11. New Bayer, United Nations Partnership Brings International Environment and Art Competition to Pittsburgh-Area Elementary and Middle Schools
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... also known as Johne,s disease, is caused by ... (MAP). In Austria, there is a legal obligation ... and causes treatment-resistant diarrhoea and wasting among affected ... for commercial farms. The animals produce less milk, ... other conditions such as udder inflammation. , ...
(Date:9/19/2014)... 19, 2014 The Canton Group, Baltimore’s leading ... website for the Xaverian Brothers. The new site aligns ... encourage and edify one another through a life of Gospel ... summons “to manifest God’s care and compassionate love to the ... was developed using a responsive web design, which allows users ...
(Date:9/19/2014)... Outsourcing services provider Profit By RPO has bagged a huge ... HR outsourcing services in India. , " Profit By RPO ... act as a talent acquisition and transformation partner. Under the ... 3 locations in India in the next four months," the ... win for us and we are delighted to collaborate with ...
(Date:9/19/2014)... The dentist at Encino Esthetic Dental ... Throughout the month of September, new patients will be able ... just $69. A complimentary home teeth whitening kit will be ... gums checked and meet the team at Encino Esthetic Dental ... protect oral health. According to the American Dental Association, biannual ...
(Date:9/19/2014)... FRIDAY, Sept. 19, 2014 (HealthDay News) -- Women of ... to maintain better oral care and visit the dentist ... Centers for Disease Control and Prevention. Researchers found ... Mexican-American, as well as those with lower income and ... Oral disease, with symptoms such as cavities or ...
Breaking Medicine News(10 mins):Health News:Lymphatic fluid used for first time to detect bovine paratuberculosis 2Health News:Xaverian Brothers Partner with The Canton Group to Launch New Website 2Health News:Profit By RPO Bags huge RPO contract from US-based Implementation Partner 2Health News:Encino Esthetic Dental Group is Now Offering a Special Promotion for New Patients 2Health News:Oral Health in Women of Childbearing Age Needs Improvement 2
... effects in patients with high-grade glioma from chemoradiation may ... radiation oncologists at the Kimmel Cancer Center at ... the April issue of the British Journal ... occurrence of early side effects, such as fatigue and ...
... prohibition against testosterone therapy in men with untreated or ... study published in The Journal of Urology . ... a history of prostate cancer, even if treated and ... to the belief that testosterone activated prostate cancer growth, ...
... secure emotional relationship with their parents, and particularly their mothers, ... , according to new research. The study suggests that ... have at least 30 percent higher odds for obesity by ... researchers accounted for other family-related factors that could provide alternative ...
... Dieters are so involved with trying to eat virtuously that they ... labeled as healthy, according to a new study in the ... names can work to their disadvantage. "Keeping your weight-loss goal ... you are careful to avoid pasta selections and instead order from ...
... INDIANAPOLIS Jason S. Meyer, Ph.D., assistant professor of ... University Indianapolis, will be honored by the largest eye ... which one day may lead to reversal of blindness ... of the retina. The Association for Research ...
... smoke a cigarette may not be enough to protect the ... to a new study in the American Journal of ... Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA ... recognized category of tobacco smokeknown as "thirdhand smoke"can have as ...
Cached Medicine News:Health News:Minimizing side effects from chemoradiation could help brain cancer patients live longer 2Health News:Study suggests another look at testosterone-prostate cancer link 2Health News:Study suggests another look at testosterone-prostate cancer link 3Health News:Quality of parent-toddler relationship could affect risk for childhood obesity 2Health News:Quality of parent-toddler relationship could affect risk for childhood obesity 3Health News:Quality of parent-toddler relationship could affect risk for childhood obesity 4Health News:When a salad is not a salad: Why are dieters easily misled by food names? 2Health News:IUPUI faculty member to receive national innovative vision research award 2Health News:LA BioMed study finds 'thirdhand smoke' poses danger to unborn babies' lungs 2
(Date:9/18/2014)... Sept. 18, 2014  Low T Center endorses ... in Hyattsville, Maryland earlier ... the proper patient population for testosterone therapy (TRT), ... associated with TRT. Examining recent claims from studies that ... "available epidemiological studies do not provide convincing evidence ...
(Date:9/18/2014)... 18, 2014   MacPractice,s MacPractice MD MU ... EHR certification, which designates that the software is capable ... and Stage 2 Meaningful Use measures required to qualify ... (ARRA).  MacPractice MD MU version 5.0 was certified on ... Office of the National Coordinator-Authorized Certification Body (ONC-ACB) and ...
(Date:9/18/2014)... 2014 This BCC Research report discusses the medical device ... growth and size, and opportunities for different devices and regions. ... Patent analysis in the report focuses on technological trends in ... Europe and Japan . ... the global medical device technologies market. - Analyze market structure, ...
Breaking Medicine Technology:Low T Center Endorses The Joint FDA Committee Meeting on Testosterone 2MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 2MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 3MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 4MacPractice MD MU Achieves ONC HIT 2014 Edition Complete EHR Certification from ICSA Labs 5Medical Devices: Technologies and Global Markets 2Medical Devices: Technologies and Global Markets 3Medical Devices: Technologies and Global Markets 4
... , , , , NASHVILLE, Tenn. and ... find that 70 percent of surveyed pharmacy directors expect to ... of chronic pain. Tanezumab, which is expected to be the ... under medical supervision, will likely be covered as a medical ...
... , , , SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. ... ), Eli Lilly and Company (NYSE: LLY ) ... results from a head-to-head study comparing exenatide once weekly, an ... in patients with type 2 diabetes. After 24 weeks of ...
Cached Medicine Technology:Majority of Surveyed Pharmacy Directors Expect To Cover Pfizer's Tanezumab If It Is Approved for the Treatment of Chronic Pain 2Majority of Surveyed Pharmacy Directors Expect To Cover Pfizer's Tanezumab If It Is Approved for the Treatment of Chronic Pain 3Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study 2Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study 3Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study 4Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study 5Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study 6Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study 7
... 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 ...
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: