FDA Approves Eli Lilly's Humulin R & KwikPen Insulin (BLA018780)

The FDA announced approval of several Humulin R insulin products from Eli Lilly and Company under application BLA018780. The approval covers brand names Humulin R and Humulin R U‑500 KwikPen, with routes parenteral and subcutaneous. Product details: Humulin R PEN and Humulin R injectable (100 U/mL) are marketed over‑the‑counter; Humulin R solution (500 U/mL) and Humulin R KwikPen (500 U/mL) are prescription‑only. All contain insulin human (recombinant or human) as the active ingredient. The FDA submission record shows labeling (submission 36, approved 1991‑03‑12) and manufacturing CMC approvals (submissions 9 and 50, approved 1984‑07‑25 and 1996‑07‑26). A recent labeling supplement was filed on 2020‑03‑23 (submission 901 required) with associated label documents. The approval adds to Eli Lilly’s insulin portfolio and provides both OTC and prescription options for diabetes management.