Sandoz launches Prograf generic capsules in US
Sandoz, the generics division of Swiss drugmaker Novartis, has launched the first generic version of Prograf capsules, an immunosuppressant to help prevent rejection of a kidney or liver transplant, in the US.
Sandoz, the generics division of Swiss drugmaker Novartis, has launched the first generic version of Prograf capsules, an immunosuppressant to help prevent rejection of a kidney or liver transplant, in the US.
The company says it is the first company to receive US approval to market its Tacrolimus capsules.
Sandoz will market the product in capsules of 0.5mg, 1mg and 5mg strengths.
Prograf lost its patent protection in the US in April 2008 and in Europe in June this year.
"Sandoz and our parent company Novartis have deep experience in the transplant field and we are deeply committed to providing more cost-saving treatment options for this community in the future," said Jeff George, chief executive of Sandoz.
Their products include cyclosporine drugs Sandimmune and Neoral, used for the prevention of organ rejection following kidney, liver or heart transplantation, as well as Myfortic (mycophenolic acid) delayed-release tablets, indicated for kidney transplants, and Simulect (basiliximab), for the prevention of acute organ rejection.
According to IMS Health, Prograf had US sales of US$929m for the year ended April 2009. It is the world's best-selling drug to stop transplanted organs from being rejected and accounts for about 20% of sales at manufacturer Astellas Pharma, headquartered in Tokyo, Japan.
The US FDA has rejected Astellas's petition to require tests to prove the safety and efficacy of immune system suppressants before approving generic versions of Prograf.
The FDA also denied Astellas's request in the petition, filed in September 2007, for labelling changes that require doctors to be notified whenever a substitute oral medicine is about to be provided to a transplant patient.
Astellas says it plans to challenge the FDA's decisions in the US District Court in Washington.
William Fitzsimmons, senior vice president of development at Astellas, said: "Transplant patients are vulnerable to small differences in drug concentrations, which can lead to significant difference in their treatment outcome."
