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