FDA Approves Ivax's Cyclosporine Capsules and Oral Solution

Ivax has received FDA approval for cyclosporine oral solution USP in a 100-mg/mL dose, and for cyclosporine capsules USP (modified) in 25-, 50- and 100-mg strengths.

The products are the generic versions of Novartis Pharmaceuticals' Neoral oral solution and Neoral capsules. Ivax said it will begin to market the products immediately through its subsidiary, Ivax Pharmaceuticals.

Cyclosporine is used as an immunosuppressant to protect against rejection after organ transplant surgery. U.S. sales of Neoral oral solution and Neoral capsules were $235.6 million in 2004, according to IMS Health.