Navigation Links
Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committee Meetings
Date:11/8/2007

BRIDGEWATER, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Ortho Biotech Products, L.P. today modified prescribing information for PROCRIT(R) (Epoetin alfa), following guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class.

The modifications to the label are based on previously reported data and include recommendations from the May 10th FDA Oncologic Drugs Advisory Committee meeting, and the September 11th joint Cardiovascular and Renal Drugs Advisory Committee/Drug Safety & Risk Management Advisory Committee meeting.

"We remain confident in the safety and efficacy of PROCRIT when used according to its FDA-approved label," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P. "This label supports physicians' abilities to customize treatment to individual patients' needs by directing them to utilize the lowest dose needed to avoid transfusions and not to exceed an upper hemoglobin safety limit of 12 grams per deciliter (g/dL)."

Label Change Details

The modifications to the label include a hemoglobin target range of 10-12 g/dL of blood for chronic renal failure patients with anemia; a hemoglobin upper limit of 12 g/dL of blood for oncology patients with anemia due to chemotherapy; and additional data regarding shortened overall survival and/or time-to-tumor progression in clinical studies in patients with advanced breast, head and neck, lymphoid, and non-small cell lung malignancies when dosed to target a hemoglobin greater than or equal to 12 g/dL. In addition, recommendations have been added for managing chronic renal failure patients who respond poorly to ESA therapy.

The boxed warnings have been modified to now read:

WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression

Renal failure: Patients experienced greater risks for death
'/>"/>

SOURCE Ortho Biotech
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Ortho Biotech Supports FDA Advisory Committees Recommendations on Use of ESAs in Chronic Renal Failure Patients
2. Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases
3. New Orthopedic Surgical Robotics Company Opens Its Doors; Files with the FDA for Clearance of Its Flagship Product
4. Innovative Neurotronics, a Subsidiary of Hanger Orthopedic Group, Earns the 2007 da Vinci Award for the WalkAide System
5. Bone-growing nanomaterial could improve orthopaedic implants
6. Advancements in Population Age and Technology Drive Future of Orthopedic Materials Market
7. Collagen Matrix, Inc. Launches OssiMend(TM) Bone Graft Matrix for Orthopedic and Spine Applications
8. Spherix Shareholders Support Companys Focus on Naturlose, Biotechnology
9. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
10. ISI Increases West Coast Life Science and Biotech Support for Emerging Companies with Expansion in San Francisco and San Diego
11. Amyris Biotechnologies Co-Founder Neil Renninger Named to Technology Reviews Prestigious TR35 List of Top Young Innovators
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Dec. 24, 2014  United Therapeutics Corporation (NASDAQ: ... Inc. (NYSE: MDT ) has submitted ... and Drug Administration (FDA) for the use of ... system (including a newly developed catheter) for use ... delivered intravenously to patients with pulmonary arterial hypertension.   ...
(Date:12/24/2014)... December 23, 2014 “Preparative & ... HPLC, Flash), Consumables (Columns, Solvents, Buffers, Valves, Guages, ... & Agriculture) - Forecasts to 2019” provides a ... opportunities, current market trends, and strategies impacting the ... estimates and forecasts of the revenue and share ...
(Date:12/24/2014)... On Friday, December 19, 2014, President ... and Continuing Resolution Appropriations Act of 2015, which ... eligible to receive funding through the Congressionally Directed ... of Defense (DoD). The Hydrocephalus Association (HA), working ... is celebrating this victory for the over 1 ...
(Date:12/24/2014)... The report expects global cell isolation and expansion market ... a carefully analyzed data about the vital drivers, restraints, ... Full Copy of Report @ http://bit.ly/1yUxy0T , ... expansion will keep witnessing growth at an impressive CAGR ... driven by rapid technological advancements, government funding and investments, ...
Breaking Biology Technology:United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 3United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 4Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 2Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 3Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 4Rare Brain Condition Now Eligible for Department of Defense Research Dollars 2The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 2The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 3
... the federal government responsible for coordinating nanotechnology research and ... North Carolina State University to craft a white paper ... should communicate potential risks associated with nanotechnology to the ... David Berube has been negotiating this project for nearly ...
... An audit of the,state stem cell agency by ... created the agency, Consumer Watchdog said today., ... found that with a,relatively minor exception the California ... of Proposition 71, the,initiative that created the agency, ...
... Announces Closing of Insider Round of Financing for ... increasing sales of,RedPath Integrated Pathology, Inc.,s PathFinderTG(R) have ... headquarters,in Pittsburgh and the growth of the company,s ... a year ago. Against this backdrop, the company ...
Cached Biology Technology:Federal government taps NC State experts to explain nanotech risks 2Controller's Stem Cell Agency Audit Ignores California Agency's Built-in Flaws 2Controller's Stem Cell Agency Audit Ignores California Agency's Built-in Flaws 3Expansion and Relocation to New, State-Of-The-Art Facilities Marks Milestone in Effort to Roll Out New Tool for Cancer Diagnosis 2Expansion and Relocation to New, State-Of-The-Art Facilities Marks Milestone in Effort to Roll Out New Tool for Cancer Diagnosis 3
(Date:12/10/2014)... 9, 2014 CIE San Diego has launched ... the connective tissue that enhances care coordination among social ... share client-level information; earned a second $1 million grant ... serving seniors aging in community and; will be recognized ... 11 th 4-6p. CIE San Diego ...
(Date:12/4/2014)... PALM BEACH GARDENS, Fla. , Dec. 3, ... identity management solutions, today announced that its DigitalPersona ... 4500 fingerprint readers have been deployed throughout ... Carolina , South Carolina ... network headquartered in Southern Pines, North ...
(Date:11/21/2014)... Strict laws against distracted driving and the ... American and European automotive sector towards gesture recognition technologies. ... that are intuitive and able to retrieve information with ... New analysis from Frost & Sullivan,s Strategic ... Europe and North America ...
Breaking Biology News(10 mins):Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 2Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 3Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 4First Bank Partners with Crossmatch to Increase Log In Security 2First Bank Partners with Crossmatch to Increase Log In Security 3Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 2Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 3Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 4
... stress a typical married couple feels during an ordinary half-hour ... from wounds by at least one day, a new study ... routinely hostile toward each other, the delay in that healing ... have major financial implications for medical centers and health care ...
... an AIDS vaccine, UCLA AIDS Institute researchers report the ... the infection in different ways. , Detailed in the ... ( http://jvi.asm.org ), the findings show that the body's ... determined. , The researchers followed the cases of male ...
... much more sophisticated visual system than previously thought, according ... which bees were able to solve complicated colour puzzles. ... of the most difficult challenges of vision - namely, ... by suggesting that bees solve this problem using their ...
Cached Biology News:Stress substantially slows human body's ability to heal 2Stress substantially slows human body's ability to heal 3UCLA scientists discover immune response to HIV differs, even in identical twins 2Bees solve complex colour puzzles 2
Natural Mouse Laminin is purified from the Engelbreth-Holm-Swarm (EHS) sarcoma and is provided in Tris-buffered saline....
... Rat adult normal paraffin tissue array ... or proteins of interest in extensive ... Rat brain, heart, kidney, liver, ... are arrayed on positively charged glass ...
... ml. Improves reproducibility and quality ... streaking.Eliminates extra spots caused by ... throughout entire 2-D runs, ensuring ... for both analytical and preparative ...
GENOMIPHI HY KIT 1000 RXN, 1 EA. Category: Genomics DNA Amplification....
Biology Products: