Generic Immunosuppressive Drug Receives FDA Approval

Officials with the FDA have approved Glenmark Pharmaceuticals’ Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg,¹ an immunosuppressive therapy.

Glenmark’s tacrolimus drug product is the generic version of Astellas Pharma’s Prograf Capsules, 0.5 mg, 1 mg and 5 mg, which is indicated for use with other medications for the prevention of organ rejection in patients who have had a liver, kidney, or heart transplant. Tacrolimus capsules are available only by prescription.²

According to Astellas Pharma, tacrolimus capsules can cause serious adverse effects (AEs) including an increased risk of some types of cancer, and increased risk of infection. Other potential AEs include diabetes, kidney problems, nervous system problems, high levels of potassium in the blood, high blood pressure, anemia, and heart problems.²

According to IQVIA data for the 12 month period ending September 2020, Astellas Pharma’s tacrolimus capsules, 0.5 mg, 1 mg and 5 mg market achieved annual sales of approximately $286.8 million.¹

REFERENCES

• Glenmark Pharmaceuticals receives ANDA approval for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg [news release]. Mumbai, India; November 11, 2020: Glenmark Pharmaceuticals. https://www.glenmarkpharma.com/sites/default/files/glenmark-received-ANDA-approval-for-Tacrolimus-Capsules-USP.PDF
• Prograf [prescribing information]. Northbrook, IL: Astellas Pharma; July 2019. Accessed November 11, 2020. https://www.prograf.com/