Gland Pharma receives USFDA approval for Acetaminophen Injection 10 mg/mL

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 approximately USD 55 million for the twelve months ending February 2025.

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