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Cumberland Pharmaceuticals receives FDA approval for updated Acetadote Injection labeling

US-based Cumberland Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for updated labeling for Acetadote (acetylcysteine) Injection.

According to the company, the new labeling revises the indication of the product and offers new dosing guidance for specific patient populations.

The new indication states, "Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen."

As part of the new labeling, Cumberland removed the product’s previous indication due to potential confusion concerning efficacy when administration within that time period is not possible.

Furthermore, the company included specific dosing guidance for patients weighing over 100kg and added new language to alert health care providers that therapy should be extended for some patients in certain clinical situations.

Cumberland Pharmaceuticals chief executive officer Kazimi said the company worked with FDA and its Division of Medication Error Prevention and Analysis (DMEPA) to improve the package insert for the product.

"The label changes reflect our commitment to this patient population, which includes development of the EDTA-free Acetadote formulation," Kazimi said.