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Semglee FDA Approval History

FDA Approved: Yes (First approved June 11, 2020)
Brand name: Semglee
Generic name: insulin glargine
Dosage form: Injection
Company: Mylan N.V. and Biocon Ltd.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Semglee (insulin glargine) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

  • Semglee has an identical amino acid sequence to Lantus (insulin glargine)¬†and is approved for the same indications.
  • Semglee 100 units/mL (U-100) injection is supplied as 10 mL multiple-dose vials and 3 mL single-patient-use prefilled pens.
  • Semglee is administered subcutaneously into the abdominal area, thigh, buttocks or upper arms once daily at any time of day, but at the same time every day.
  • Side effects include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.

Development Timeline for Semglee

Jun 11, 2020Approval  FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.