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.
