In response to numerous calls from AASV members, Dr. Tom Burkgren has been in contact with the FDA’s Center for Veterinary Medicine (CVM) to express the importance of accessing supplies of injectable 200mg iron dextran and PG600.
Dr. Bernadette Dunham, Director FDA, CVM, assured Dr. Burkgren that the US manufacturer of 200 mg iron dextran has sufficient product in the pipeline to take care of all the industry’s needs. The 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.
With regards to PG600, Dr. Dunham indicates that the FDA "hold" on PG600 will be released "very" soon and product will then be allowed to be shipped.
FDA was very helpful in working with the AASV to facilitate the importation of injectable iron products to help alleviate recent shortages. Hopefully the announcement today will further resolve these product issues.