Novo Nordisk A/S has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the approval of NN304 (insulin detemir), a long-acting insulin analog for the treatment of diabetes mellitus.

NN304 (insulin detemir) is designed to provide an improved basal insulin profile which is smoother, longer-acting and with less day-to-day variation than conventional NPH insulin preparations. Novo Nordisk anticipates an indication for use in individuals with both type 1 and type 2 diabetes.

On November 5, Novo Nordisk submitted a Marketing Authorization Application (MAA) to the European Medicines Evaluation Agency (EMEA) for the approval of NN304 in Europe.

Upon approval of NN304 (insulin detemir) by the regulatory authorities, Novo Nordisk will be the only diabetes company with a complete insulin analog portfolio comprising rapid-acting, premixed and long-acting insulin analog products.

The filing of NN304 (insulin detemir) will not impact Novo Nordisk's expectations for the financial results for 2002.