Federal Bid

Last Updated on 21 Sep 2013 at 8 AM
Combined Synopsis/Solicitation
Location Unknown

Evaluate the therapeutic equivalence of generic sodium ferric gluconate iron complex Nulecit™ and its RLD Ferrlecit®.

Solicitation ID FDA-SOL-1120929R
Posted Date 19 Aug 2013 at 7 PM
Archive Date 21 Sep 2013 at 5 AM
NAICS Category
Product Service Code
Set Aside No Set-Aside Used
Contracting Office Office Of Acquisitions And Grants Services - Rockville
Agency Department Of Health And Human Services
Location United states
The objective of this study is to evaluate the therapeutic equivalence of generic sodium ferric gluconate iron complex NulecitTM and its RLD Ferrlecit®. Specific aims are: 1) compare reticuloendothelial system (RES) uptake of RLD and generic; 2) compare biodistribution of the RLD and generic in animal models; 3) conduct in-vivo study to compare plasma NTBI levels and oxidative stress after i.v. administration of RLD and generic in healthy subjects or patients. This study is part of post-market surveillance that can help address potential concerns regarding the quality of generic iron complex products and support the Agency's review standards
Bid Protests Not Available