Federal Register Notice: FDA has determined the regulatory review period for Amylin Pharmaceuticals’ Symlin is 4,620 days (pramlintide acetate) for extending a patent which claims the human drug product. FDA recently approved Symlin for marketing as an adjunct treatment in Type 1 diabetes patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, and for Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin. To view this notice, click here.