FDA Approves Lorazepam Injectable (ATIVAN) NDA018140

The U.S. Food and Drug Administration (FDA) has approved application NDA018140 for the benzodiazepine Lorazepam, marketed under the brand name ATIVAN as an injectable product. The approval includes two injectable strengths—2 mg/mL (product number 001) and 4 mg/mL (product number 002)—intended for intramuscular or intravenous administration. Both products are classified as prescription‑only human drugs. Manufacturing responsibility is shared by Hikma Pharmaceuticals USA Inc. and Civica, Inc., with the products listed under several NDC codes such as 0641‑6207‑01. This approval follows a series of FDA submissions, including a labeling update submitted in February 2021 (submission 46) and earlier manufacturing and labeling submissions dating back to 1987 and 2006.