Navigation Links
Bayer Establishes US Special Access Program for Leukine(R) While Replacing Current Liquid Formulation
Date:1/23/2008

- Leukine lyophilized formulation temporarily reserved for patients with

Acute Myelogenous Leukemia (AML) and those experiencing bone marrow

transplantation graft failure or engraftment delay - Bayer will replace current 500 mcg liquid formulation; aims to restore US

supplies of Leukine to current levels as quickly as possible

WAYNE, N.J., Jan. 23 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today, following consultation with the United States Food and Drug Administration (FDA), that it will withdraw the current liquid formulation of Leukine(R) marketed in the US. This decision was made in light of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with the liquid Leukine 500 mcg vial which currently contains EDTA (edetate disodium).

While Bayer works to increase supplies of lyophilized Leukine and reformulate the liquid Leukine (to eliminate EDTA), Bayer will establish a special access program for the currently marketed lyophilized Leukine 250 mcg vial which does not contain EDTA. The upward trend in adverse event reporting rates is only associated with the Leukine liquid 500 mcg vial containing EDTA. Bayer has not observed an upward trend in reporting rates of these adverse events in the marketed Leukine 250 mcg lyophilized vial which does not contain EDTA. These adverse reactions are listed in the Leukine prescribing information.

The special access program is designed to prioritize the supply of the lyophilized Leukine for patients with Acute Myelogenous Leukemia (AML) and those who are experiencing bone marrow transplantation engraftment failure or delay. Leukine is the only myeloid growth factor approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with AML and to prolong survival of patients with bone marrow graft failure or engraftment delay, as co
'/>"/>

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

Page: 1 2 3 4

Related medicine news :

1. Bayer Corporation Renames Its U.S. Foundation, Refocuses Charitable Giving Areas
2. New Bayer, United Nations Partnership Brings International Environment and Art Competition to Local Elementary and Middle Schools
3. New Bayer, United Nations Partnership Brings International Environment and Art Competition to Pittsburgh-Area Elementary and Middle Schools
4. New Bayer, United Nations Partnership Brings International Environment and Art Competition to Northern New Jersey Elementary and Middle Schools
5. New Bayer, United Nations Partnership Brings International Environment and Art Competition to Kansas City Area Elementary and Middle Schools
6. AUDIO from Medialink and Bayer: Use Caution When Choosing Your Cold Medicine
7. Bayer CropScience, Mertec and M.S. Technologies to Co-Develop New Soybean Trait Products
8. Bayer HealthCare Pharmaceuticals and MedAssets Supply Chain Systems Sign a Three-Year Agreement for Magnevist(R) Magnetic Resonance Contrast Media
9. Bayer Awards Making Science Make Sense Grant to Girl Scouts
10. Bayer Plants Trees With Chartiers Valley Intermediate School Students, Provides Free Environmental Education Materials
11. AUDIO from Medialink and Bayer: Lifesaving Benefits of Low-Dose Aspirin Therapy Maintained with Naproxen Sodium
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/12/2014)... (PRWEB) July 12, 2014 The report, ... Alkyd Resins) Market by Application & Geography – Trends ... market with analysis and forecasting of market volume and ... of the derivatives separately. The market of phthalic anhydride ... in 2013 to $8,415.89 million by 2018, with a ...
(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)... The fastest-growing mobile technology is LTE (Long Term Evolution). ... continues to grow due to the rapid evolution of ... data traffic, which is a major driver for the ... Measurement equipment comply with industry standards, and services which ... Market is estimated to grown from $3.75 billion in ...
(Date:7/12/2014)... 2014 (HealthDay News) -- If you make exercise fun, you,ll ... one experiment, 56 adults were led on a 1.4-mile walk ... or a scenic walk. The participants were given lunch after ... exercise outing ate 35 percent more chocolate pudding for dessert ... In another experiment, 46 adults were given mid-afternoon snacks ...
(Date:7/12/2014)... 2014 Sean Francis, owner of the Kawartha Lakes ... to his clients. He’s also known for his support of local ... way to combine the two and is excited to announce that ... Boys and Girls Club. , The funds are the result of ... 23rd. Francis sent out emails and asked his clients to put ...
Breaking Medicine News(10 mins):Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 4Health 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 Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 4Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 5Health News:Make Exercise Fun, Eat Less Afterwards 2Health News:Kawartha Lakes Fit Body Boot Camp’s Successful Fat Loss Challenge Results in $2,000 to Boys and Girls Club 2Health News:Kawartha Lakes Fit Body Boot Camp’s Successful Fat Loss Challenge Results in $2,000 to Boys and Girls Club 3
... Calif., Nov. 19 ,Natrol, Inc, (Nasdaq: NTOL ... nutritional products, and Gener8Xion Entertainment, Inc.,(OTC Bulletin Board: ... a letter of intent for a strategic,alliance to ... intends to,exclusively license the "Living Pure" brand to ...
... as World,s Leading Thoroughbred ... Radiography Review, SANTA CLARA, Calif., Nov. 19 ... doors to the,annual September Yearling Sale, the medical repository ... medical images. Beginning with 12,review workstations from Eklin Medical ...
... HCA Study Reveals Qualities of High-Performing Organizations, ... from The Beryl,Institute, titled "High Performing Organizations: Culture ... satisfaction are highly,correlated with outstanding clinical care and ... bottom line. Using the,results of a study done ...
... Nov. 19 Boston Scientific,Corporation (NYSE: BSX ... been,reached to settle claims associated with a series ... and 2006. Boston Scientific acquired,Guidant last year. This ... July 2007 to cover additional unanticipated claims. ...
... - ... 8,550 Patient Plaintiffs -, MINNEAPOLIS, Nov. 19 ... Medical Device Litigation,announced today that an amended settlement agreement ... asserted claims against Guidant,Corporation, Boston Scientific Corporation and other ...
... Flagship Global Health,Inc. (OTC Bulletin Board: FGHH), a ... priority access to, the world,s leading,doctors has added ... and services field to lead its Marketing and ... marketing and sales at Flagship,Global Health and, in ...
Cached Medicine News:Health News:Natrol, Inc. (Nasdaq: NTOL) and Gener8Xion Entertainment (BB: GNXE) Announce Strategic Alliance to Create a New Health and Wellness Division 2Health News:Natrol, Inc. (Nasdaq: NTOL) and Gener8Xion Entertainment (BB: GNXE) Announce Strategic Alliance to Create a New Health and Wellness Division 3Health News:Natrol, Inc. (Nasdaq: NTOL) and Gener8Xion Entertainment (BB: GNXE) Announce Strategic Alliance to Create a New Health and Wellness Division 4Health News:Keeneland Scales Eklin Digital Repository(TM) to 32 Medical Image Review Workstations 2Health News:Keeneland Scales Eklin Digital Repository(TM) to 32 Medical Image Review Workstations 3Health News:Boston Scientific Announces Amended Agreement to Settle Product Lawsuits 2Health News:Boston Scientific Announces Amended Agreement to Settle Product Lawsuits 3Health News:Plaintiffs Obtain $240 Million Amended Settlement In Guidant Defibrillators Products Liability Litigation 2Health News:Flagship Global Health Hires Health Care Veteran Larsen to Head Marketing and Sales 2
(Date:7/10/2014)... July 10, 2014 Yesterday, former Congressman ... medical device manufacturing facility. Rep. Kennedy and ... monitors facilitate cutting-edge research in neurological disease and ... mental health advocate, Garen Staglin , created ... fostering fundamental changes that will radically accelerate the ...
(Date:7/10/2014)... 2014  Valeant Pharmaceuticals International, Inc. (NYSE: ... completed the sale to Galderma of all rights to ... by Valeant for $1.4 billion in cash, pursuant to ... completed its acquisition of Galderma. "We ... to a company that is firmly committed to the ...
(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 ...
Breaking Medicine Technology:Representative Patrick Kennedy visits Moberg's medical device facility to discuss improvement in brain injury care 2Long-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) 3
... CITY, Calif., Feb. 17, 2012 Codexis, Inc. (NASDAQ: ... to enable the production of biofuels, bio-based chemicals, and ... of Directors has appointed Peter Strumph as the company,s ... as President and Chief Executive Officer and from the ...
... Pharmaceuticals Holdings (Nasdaq: ENDP ) today announced that ... overview at the J.P. Morgan Annual Global High Yield & ... a.m. ET.  The conference will be held at the Loews ... and audio archive of the presentation will be available on ...
Cached Medicine Technology:Codexis Appoints Interim Chief Executive Officer 2
The CGPL capsulotomy contact glass was designed by Riquin, Fankhauser et al. for the dissection of opacified posterior lens capsules and membranes in the pupillary and retropupillary space with the Y...
The CGAL gonioscopic contact glass was designed by Roussel and Fankhauser for,laser treatments of the chamber angle. It reduces the laser spot by a factor of 1.5 as compared to a Goldmann Glass....
The CGRL is a Wide Angle Contact Glass designed for laser photocoagulation and diagnosis of the retina....
The classic Goldmann Glass. Designed to work with argon/YAG Lasers....
Medicine Products: