Parsippany, New Jersey. Edenbridge Pharmaceuticals is aware of interest in and media reports related to the potential use of Ivermectin for the prevention and/or treatment of COVID-19. Edenbridge’s Ivermectin tablets, USP (3mg) are not approved by the U.S. Food and Drug Administration (FDA) for use in the prevention or treatment of COVID-19. However, in light of the ongoing global pandemic and reports throughout the scientific and medical communities related to Ivermectin, Edenbridge is supporting certain clinical trials to study the safety and effectiveness of Ivermectin for the treatment of COVID-19. As these studies are ongoing, no further comment or information is available at this time.
Edenbridge Pharmaceuticals is also aware of unsubstantiated reports of fake or recalled lots of its Ivermectin tablets, USP (3mg). Edenbridge Pharmaceuticals’ Ivermectin tablets, USP (3mg) were approved for human use by the FDA in 2014 for the treatment of strongyloidiasis of the intestinal tract and onchocerciasis. Since that time and to date, no lot of this product has been recalled or is currently being recalled.
Edenbridge Pharmaceuticals utilizes a contract manufacturer and two contract packagers for its Ivermectin tablets, USP (3mg). The manufacturer and both packagers are located in the United States and are all in good standing with the FDA and routinely audited. Due to differences in packaging equipment, there are some slight differences in the packaging. The printing on the blisters may be different in one lot versus another, including differences in font and character formation (e.g., a slash through the zeros). In addition, the blister card and carton may vary slightly in width and the blister or bubble may vary slightly in size. While these differences may have raised some concerns, they are all necessary to properly package the product with relevant quality controls in place to ensure a complete seal of the blister and accurate printing on the blisters.
More information on Edenbridge Pharmaceuticals’ Ivermectin tablets, USP (3mg) can be found in the package insert for the product available here.