05:27 AM EST, 12/10/2024 (MT Newswires) -- (Updates with the stock move in the headline and second paragraph.)

Cumberland Pharmaceuticals ( CPIX ) said the US Food and Drug Administration approved a supplemental new drug application for acetadote, simplifying the administration of the dosing regimen.

Cumberland's share price more than doubled in premarket activity on Tuesday.

Acetadote is an intravenous formulation of N-acetylcysteine indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen, the company said late Monday.

"This streamlined approach has been implemented in hospitals across multiple countries and demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions without compromising the effectiveness of acetadote," the company added.