FDA Approves ANDA076330 for Octreotide Acetate Injection

The U.S. Food and Drug Administration (FDA) has approved application number ANDA076330 for octreotide acetate injectable products. The approved products are manufactured by Hikma Pharmaceuticals USA Inc. and marketed under the brand name Octreotide Acetate. Two injectable formulations are listed: product 001 with a strength of 0.2 mg per mL and product 002 with a strength of 1 mg per mL. Both are designated for injection via intravenous or subcutaneous routes and are classified as human prescription drugs. The sponsor for the application is West‑Ward Pharms International. The approval follows a series of labeling submissions (numbers 4, 9, 13, 16, 18, and 20), the latest of which was submitted on September 16, 2022. Both products are identified as reference standards in the FDA’s records.