SANOFI AVENTIS US — Lantus FDA Review (NDA/BLA 021081, 2020)

Report summary

This FDA approval package details the supplemental new drug application for Sanofi-aventis's Lantus (insulin glargine) Injection, 100 U/mL, specifically for the addition of the SoloStar disposable insulin injection device, approved April 25, 2007. The report covers Lantus's indications, mechanism, pharmacodynamics, pharmacokinetics, and clinical study results in adult and pediatric patients. It also addresses safety, administration, storage, and adverse reactions, including specific population considerations. Regulatory review of the SoloStar pen included chemistry, manufacturing, and controls (CMC), labeling changes, and safety evaluations by DMETS and CDRH. DMETS raised concerns about potential medication errors due to similar packaging, labeling, and patient misuse, recommending improved labeling and instructions. Despite these concerns, the SoloStar pen was recommended for approval.

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