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Novo Nordisk Receives ‘Approvable Letter’ From FDA
Long-Acting Insulin Will Compete Against Lantus
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.
Categories: Food, Government & Policy, Insulin, Lantus, Novo Nordisk, Type 1 Issues
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Feb 1, 2004
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Diabetes Health
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.
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Topics
- Diabetic / Diabetes Health
- Type 1 / 1.5 Diabetes
- Type 2 Diabetes
- Blood Glucose / Sugar
- High/Low Blood Sugar / Fast Acting Glucose
- Insulin- Pumps, Pens & Syringes
- Continuous Glucose Monitors, CGM, Infusion Sets
- Type 2 Medications
- Hyperglycemia
- Hypoglycemia
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