Aurobindo Receives FDA Approval for Cyclosporine Capsules USP (Modified) (Soft Gelatin Capsules), 25 mg, 50 mg, and 100 mg
Published: September 17, 2026
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Cyclosporine Capsules USP (Modified) (Soft Gelatin Capsules), 25 mg, 50 mg, and 100 mg. Aurobindo Pharma’s Cyclosporine Capsules USP (Modified), are an AB-rated generic equivalent to the reference listed drug (RLD), Neoral® Capsules, manufactured by Novartis Pharmaceuticals Corporation.
Cyclosporine Capsules USP (Modified) are indicated for the:
- Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
- Treatment of patients with severe active, rheumatoid arthritis.
- Treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis
