SangStat Files For US Ciclosporin Approval
SangStat has filed for marketing clearance with the US Food and Drug Administration for a generic version of Sandoz' immunosuppressive drug ciclosporin, for use in transplantation. It is likely to be the only company in the near future to offer a generic ciclosporin and be able to carve a market share in the $1.2 billion market.
The application includes results of a pivotal trial which demonstrate that SangStat's ciclosporin formulation is bioequivalent to the branded ciclosporin. Eli Lilly is to manufacture the drug, with SangStat retaining worldwide commercial rights to the product.
The FDA has approved the last three transplant drugs in 12, nine and three months, respectively. SangStat is therefore hopeful of a speedy approval process, said Philippe Pouletty, managing director and chairman of the company.
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