Alpharma Inc announced that a recent federal court judgment supports an earlier finding by the Food & Drug Administration that the FDA has no record of approval for certain product claims made by PennField Oil Co. for its bacitracin methylene disalicylate product, a medicated feed additive for livestock and poultry.
Alpharma is the sole manufacturer of bacitracin methylene disalicylate, sold under the registered trademark BMD, in the U.S. market entitled to make the full range of FDA-approved claims for performance important to producers of swine and poultry. Earlier this year, Alpharma sued the FDA in the U.S. District Court for the District of Maryland over the scope of label claims PennField is making for its product.
"Alpharma sees this swift federal court action supporting the FDA's limit on the claims our competitor can make as an important victory, not only for our proprietary, fully FDA-approved product, but more importantly for our customers, who deserve and expect accurately and legally labeled animal health products," said Carol Wrenn, President, Alpharma Animal Health. "We are confident that FDA and state feed control regulators will take all appropriate enforcement actions against improperly labeled products in the marketplace based on this court decision and recent FDA actions," she said.