Navigation Links
American Regent Resumes Shipment of VENOFER® (iron sucrose injection, USP)
Date:5/3/2011

SHIRLEY, N.Y., May 3, 2011 /PRNewswire/ -- American Regent announces that, effective immediately, it has resumed the shipment of Venofer® (iron sucrose injection, USP).  

Please Note: ALL sizes of Venofer® (50mg/2.5mL, 100mg/5mL and 200mg/10mL Single Dose Vials) are available through your local Wholesaler or Distributor. Drop shipments through your wholesaler are also available.

American Regent has filled all open orders for Venofer® and has over 1 million vials in inventory.  Future shortages or further disruptions in supply are not expected. American Regent estimates that it will resume manufacturing of Venofer® on May 16, 2011.

On April 21, 2011 American Regent announced the temporary suspension of the distribution and manufacture of products at its Shirley, N.Y. facility in response to an FDA inspection due to the presence of particulate matter in a few of its "generic" injectables. This temporary suspension was necessary to allow American Regent to assess and remediate its quality systems.

There were no product or quality issues raised by FDA specifically to Venofer®, however, American Regent had independent cGMP consultants perform a Product Quality Assessment on Venofer®, verifying the integrity of the product. American Regent confirms that Venofer® meets all USP and internal quality release specifications for Iron Sucrose Injection and that no changes have been made to the formulation of the product. The quality of today's Venofer® is the same as the 75 million vials of Venofer® prescribed to patients in the U.S. since it was first introduced 10 years ago.

American Regent appreciates the tremendous support of all our customers and partners have given us during this period and for your continued loyalty and confidence in Venofer®.

Venofer® (iron sucrose injection, USP) is indicated in the treatment of iron deficiency anemia in the following adult patients:

  • Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
  • Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
  • Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
  • Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin

If you have any questions or need to place an order for a "drop shipment" please contact our Customer Service Department at 1-800-645-1706 or for more information on Venofer® visit our website at:  www.venofer.com


'/>"/>
SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... 12 februari 2016 AAIPharma Services ... leverancier van productie en ontwikkeling op maat ... vandaag een uitbreiding aan van steriele vul- ... in Charleston, SC . ... meerdere recente investeringen. http://photos.prnewswire.com/prnh/20150806/256637LOGO ...
(Date:2/11/2016)... - Cardiac Marker Diagnostic ... and Cancer Therapy. - European Point of Care ... - Key Diagnostic Testing Markets. - Molecular ... Genetic Testing. - Molecular Diagnostics in Infectious Disease ... Diagnostic Products World Markets. - Point of Care ...
(Date:2/11/2016)... -- Laboratory glassware and plasticware include equipment, ... range from microscope slides to large storage boxes and ... glass because of its low weight and resistance to ... gaining popularity over the past decade when it was ... plastic in several applications due to its resistance to ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... 12, 2016 , ... According to an article published February 4th ... significant portion of hernia repairs throughout the United States. Commenting on this article, Beverly ... that this trend has not only been expected, but it seems to be a ...
(Date:2/12/2016)... Raton, FL (PRWEB) , ... February 12, 2016 ... ... largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving the ... services – hosted over 250 members of South Florida’s philanthropic community at its ...
(Date:2/12/2016)... ... February 12, 2016 , ... As a former television executive, ... demanding job, and no time to decompress, Rabinowitz found herself drawn to a casual ... for its impact on her life, implementing a 20-minute-per-day meditation practice with her team. ...
(Date:2/12/2016)... ... February 12, 2016 , ... Itopia, a leader ... integration of Clarity Intelligence Platform (CIP) into Cielo®, a discovery, migration and cloud ... (BI) to their small and medium business (SMB) clients. , In ...
(Date:2/12/2016)... ... February 12, 2016 , ... The Jones Agency, a family owned ... Texas, is launching a cooperative charity drive with the Tarrant Area Food Bank in ... 50,000 individuals and families in need, the Tarrant County Food Bank offers hope and ...
Breaking Medicine News(10 mins):