Bernadette Dunham, CVM director, assured AASV that the U.S. manufacturer of 200 mg iron dextran, Sparhawk, has sufficient product in the pipeline to take care of all the industry’s needs.
FDA was very helpful in working with the AASV to facilitate the importation of injectable iron products to help alleviate recent shortages. A Canadian manufacturer was allowed to ship product to the US in July but will not be allowed in the future unless a NADA is issued for that product.
Dunham indicates that the FDA “hold” on PG600 will be released soon and product will then be shipped. Related Website
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