Newtown, PA, November 11, 2020.
STI Pharma, LLC (“STI”) announced the US launch of Arsenic Trioxide injection, 10 mg/10 mL strength, for which STI has received final approval by the US Food and Drug Administration for its Abbreviated New Drug Application, (ANDA). This launch adds to STI’s growing portfolio of generic injectables.
Arsenic Trioxide is the AP rated generic equivalent of the antineoplastic agent Trisenox. According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Arsenic Trioxide Injection, USP, for the 12 months ending October 2020 were approximately $32 million
Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Important Safety information includes the possibility of Differentiation Syndrome and Cardiac Conduction Abnormalities.
Reported adverse reactions include Differentiation Syndrome Cardiac Conduction Abnormalities, Hepatotoxicity, Carcinogenesis and Embryo-Fetal Toxicity
See Package Insert (PI) for full prescribing information and complete safety information: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f684f18f-afae-4430-a6af-63aae21b3571