The FDA has informed us that Bimeda will be releasing approximately 40,000 bottles of 200mg iron by the end of next week. This release will likely come in 2 shipments of 20,000 bottles each with the first shipment occurring by the end of this week. The agency also confirmed that Sparhawk will be shipping 40,000 bottles of 100mg product this week as well.
In addition, Bimeda informed the FDA that they would likely have additional product available for shipment toward the end of the month. Of concern is that Bimeda was approved to ship product only until their waiver expires on February 28. To ship beyond that date will require a waiver extension according to contacts at FDA.
AASV has been in frequent contact with FDA’s Center for Veterinary Medicine regarding this potential shortage and has been assured that FDA is continuing to monitor the situation and working toward ensuring an adequate supply. We informed the agency that the industry treats approximately 2 million piglets per week with injectable iron and expressed concern about the equitable distribution of the available product.
We will continue to work with the FDA to resolve this issue.