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:1/19/2017)... -- Accuray Incorporated (Nasdaq: ARAY ) announced ... set the bar for excellence in customer satisfaction. The ... rating among radiation treatment delivery systems in the U.S., ... Briefing™. The most recent ratings trend also shows Accuray ... for 11 of the past 12 quarters. ...
(Date:1/19/2017)... CLEVELAND , Jan. 19, 2017 ViewRay, ... (DFG), a federal institution supporting research in ... installation and patient treatments at the University Clinic Heidelberg ... The MRIdian Linac program will be headed ... who also heads radiation oncology at the German Cancer ...
(Date:1/19/2017)... , January 19, 2017 ... Option to Address Motor Symptoms and Motor Complications ... ...      (Logo: http://photos.prnewswire.com/prnh/20151014/276718LOGO) ... , European Neurological Review,2016;11(Suppl. 2): 2-15, http://www.touchneurology.com/articles/safinamide-new-therapeutic-option-address-motor-symptoms-and-motor-complications-mid-late ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... Spectrum Aquatics Launches New ADA Portable Motion Trek BP 300 ... the lift is mounted on wheels, it can be wheeled out of the way and ... fasten to the deck. "We have transformed the feedback from customers into specific enhancements and ...
(Date:1/20/2017)... ... 20, 2017 , ... Source Vitál Apothecary, a skin and body care company ... the company had a successful visit to the 2017 ECRM Diet, Vitamin & Sports ... work in the nutritional, sports and health industries a chance to meet in private ...
(Date:1/20/2017)... Florida (PRWEB) , ... January 20, 2017 , ... Lice ... head lice cases in families with school-aged children since the holiday season. , ... the holidays with their families, sharing hugs and taking photos, which is the head-to-head ...
(Date:1/20/2017)... ... January 20, 2017 , ... Michael and Betsy Brauser celebrated 5 years of ... the clinical trial has been life-saving as she has been on the trial ... Brauser was diagnosed with ovarian cancer in 2009. She underwent standard chemotherapy but a ...
(Date:1/20/2017)... ... 20, 2017 , ... “Mary Magdalene: Grace is Greater than Sin”: a ... witnessed Jesus Christ firsthand. “Mary Magdalene: Grace is Greater than Sin” is the creation ... educator interacting with countless women who had little knowledge of the female characters portrayed ...
Breaking Medicine News(10 mins):