Ivax Corporation has received final FDA approvals for its Abbreviated New Drug Applications (ANDAs) for cyclosporine oral solution USP, 100 mg/mL and cyclosporine capsules USP (Modified) in 25 mg, 50 mg and 100 mg strengths.
Ivax will immediately market these products through its subsidiary, Ivax Pharmaceuticals, Inc. Cyclosporine oral solution USP, 100 mg/mL is the generic equivalent of Neoral oral solution, 100 mg/mL and cyclosporine capsules are the generic equivalent of Neoral capsules. The Neoral products are marketed by Novartis Pharmaceuticals Corporation and used as immunosuppressants to protect against rejection following organ transplantation.
According to IMS data, US sales of Neoral oral solution 100 mg/mL and Neoral capsules, 25, 50, 100 mg and cyclosporine oral solution USP, 100 mg/mL and cyclosporine capsules USP, 25, 50, 100 mg were $235.6 million during 2004.
Ivax continues its aggressive filing schedule for new ANDA submissions, a company release said.
Ivax Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the US and internationally.