Pharmaceutical Business review

Nexus Pharmaceuticals gets FDA nod for Arsenic Trioxide injection in 10mg per 10mL vial

Image: Arsenic Trioxide 10mg/10ml vial. Photo: courtesy of Business Wire.

Nexus Pharmaceuticals chief commercial officer Omair Ahmed said: “The approval of generic Arsenic Trioxide injection continues to show Nexus’s commitment in providing access to affordable critical-need generic injectables.

“Collectively, as drug manufacturers and healthcare providers, we have a commitment to patients to ensure they are receiving affordable drugs they need, when they need them, which is why we make it our highest priority to be a reliable partner in supplying critical need drugs.”

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.

The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, e de ma, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia and dizziness.

Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice.

Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

Source: Company Press Release