Generic Deferasirox Tablets Granted FDA Approval

Officials with the FDA have granted final approval to Glenmark Pharmaceuticals’ Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg. The drug is the generic version of Exjade® (deferasirox, Novartis) Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg.¹

Deferasirox is indicated for treating chronic iron overload caused by repeated blood transfusions in patients age 2 years and older.²

Common adverse effects reported by patients in clinical trials taking deferasirox include nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory values, and skin rash. A boxed warning on Novartis’ deferasirox label indicates the drug may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines.²

According to IQVIA sales data for the 12-month period ending November 2019, Norvartis’ deferasirox tablets for Oral Suspension, 125 mg, 250 mg and 500 mg garnered annual sales of approximately $106.4 million.¹

REFERENCES

• Glenmark Pharmaceuticals receives ANDA approval for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg [news release]. Mumbai, India; January 7, 2020: Glenmark website. https://www.glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Deferasirox-Tablets-for-Oral-Suspens.pdf. Accessed January 7, 2020.
• Novartis. Exjade® (deferasirox) tablets for oral suspension. Novartis website. https://www.us.exjade.com/. Published November 2019. Accessed January 7, 2020.