Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Acetaminophen Injection, 10 mg/mL (500mg/50mL and 1000mg/100mL) Bags. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Acetaminophen Injection, 500 mg/50 mL (10 mg/mL) and 1000 mg/100 mL (10 mg/mL), of B. Braun Medical, Inc.
This product is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, as well as moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older. The company expects to launch this product through its marketing partner in the near future. According to IQVIA, the product had US sales of around $55 million for the twelve months ending February 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
