Federal Register Notice: FDA has determined the regulatory review period for Sanofi aventis’ Lantus is 1,591 days for extending a patent which claims the human drug product. Lantus is indicated for once-daily subcutaneous administration for treating adult and pediatric patients with Type 1 diabetes mellitus or adult patients with Type 2 diabetes mellitus who require basal (long-acting) insulin for controlling hyperglycemia. To view this notice, click here.
