Novo Nordisk Receives ‘Approvable Letter’ From FDA

On October 8, 2003, Novo Nordisk announced that it had received an “Approvable Letter” from the U.S. Food and Drug Administration (FDA) for insulin detemir, its long-acting insulin analog.

At present, Lantus (insulin glargine), manufactured by Aventis, is the only long-acting insulin analog on the market.

In the letter, the FDA requests that Novo Nordisk address certain clinical issues and provide additional information before U.S. marketing approval can be granted. The company says that it is working with the FDA to clarify and resolve outstanding issues.

Novo Nordisk expects to provide an update of the timeline for U.S. approval when it releases its 2003 financial statement on February 5, 2004 pending completion of consultations with the FDA.

-October 8,2003, Novo Nordisk Stock Exchange announcement.

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