Federal Register Notice: FDA has determined the regulatory review period for Novo Nordisk’s Levemir (insulin determir (rDNA origin)) is 2,896 days for the extension of a patent that claims the human drug product. Levemir is indicated for once or twice-daily subcutaneous administration treating adult patients with diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. To view this notice, click here.
