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Levemir Approval History

  • FDA approved: Yes (First approved June 16th, 2005)
  • Brand name: Levemir
  • Generic name: insulin detemir
  • Dosage form: Injection
  • Company: Novo Nordisk Inc.
  • Treatment for: Diabetes, Type 1, Diabetes, Type 2

Levemir (insulin detemir) is a novel, long- acting form of insulin that provides up to a 24-hour duration of action for the treatment of diabetes mellitus (type 1 and type 2).

Development History and FDA Approval Process for Levemir

May 22, 2012Approval FDA Approves Levemir for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
Apr  2, 2012Approval FDA Approves Levemir Pregnancy Category Change for Women with Diabetes
Jun 16, 2005Approval Levemir Novo Nordisk Inc. - Treatment for Diabetes Mellitus (Type 1 and Type 2)

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