It is also indicated to treat patients who exhibit early-onset and severe or life-threatening toxicity affecting cardiac or central nervous system, and early-onset and unusually severe adverse reactions within 96 hours after the end of treatment with 5-FU or capecitabine.
The drug is claimed to be the first and only antidote for emergency treatment following an overdose of the chemotherapy agents.
Wellstat's commercialisation partner BTG will market and distribute the drug in the US.
"Wellstat has developed Vistoguard to help patients treated with 5-FU or capecitabine who develop severe or life threatening toxicity or experience an overdose."
Wellstat Therapeutics CEO Samuel Wohlstadter said: "Wellstat has developed Vistoguard to help patients treated with 5-FU or capecitabine who develop severe or life threatening toxicity or experience an overdose.
"It is the only treatment approved by the FDA for early onset severe toxicities or 5-FU overdose and now will be available to the thousands of patients impacted by this condition."
The approval was based on data from a development program in 135 patients, which demonstrated the efficacy and safety of a single course of 10g given orally every six hours for a total of 20 doses.
According to the firm, the studies showed that overall survival of patients with 5-FU toxicity receiving Vistoguard was 96% compared against 16%in historical cases employing standard supportive care measures.
Vistoguard also received orphan drug designation from the FDA as an antidote in the treatment of 5-FU poisoning and from the European Medicines Agency (EMA) as a treatment for 5-FU overdose.
