By: IPP Bureau
Last updated : April 04, 2025 11:06 am
The company expects to launch this product through its marketing partner in the near future
Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for AcetaminophenInjection, 10 mg/mL (500mg/50mL and 1000mg/l100 mL) Bags.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Acetaminophen Injection, 500 mg/50 mL (10 mg/mL) and 1,000 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 paediatric 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 approximately US $55 million for the twelve months ending February 2025.