Patent Certifications and Suitability Petitions

This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

Waltham, Mass. – Slade Gorton & Co., Inc, is recalling lot 3896 of Wellsley Farms Farm-Raised Atlantic Salmon sold in 2-lb bags at BJ’s Wholesale Club stores due to the potential for the product to be contaminated with Listeria monocytogenes.
Although healthy individuals may suffer only short-term s

The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false and misleading claims regarding compounded GLP-1 products offered on their websites.

The Food and Drug Administration is advising consumers not to purchase or use VITAFER-L Gold 500ml, a product promoted for energy and sexual enhancement on various websites, including www.amazon.com and www.walmart.com.

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.

ENDICO POTATOES of MOUNT VERNON NY is recalling Endico brand PEAS AND CARROTS AND MIXED VEGETABLES, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other