Amneal Pharmaceuticals is rolling out its generic of Trisenox (arsenic trioxide injection. The drug, which had already been approved by the Food and Drug Administration, is indicated to treat acute promyelocytic leukemia.
The generic comes with a boxed warning on differentiation syndrome, cardiac conduction abnormalities and encephalopathy including Wernicke’s.
Amnea said its generic Trisenox would be available in packes of to single-dose vials in dosage strengths of 1 mg/ml and 2 mg/ml.
Arsenic trioxide injection had a market size of $26.3 million for the year ended July 2021, according to data from IQVIA.