FDA Plays

[pcrutch]

It's most likely because they didnt run a study to compare the two properly. I'm curious what kind of data they have submitted, but I imagine most of it comes from post-marketing surveillance. If anything, Maybe they changed their language to not suggest FUSILEV is safer or more effective?

The indication might be large, but they charge about 9-10 times the generic price. That price could change with a bigger indication. They really only have sales right now because the generic manufacturers( TEVA, Barr(?) ) have had problems making it. Once those issues are settled, you'd expect FUSILEV sales to decline.

See here for more information

http://www.ahfsdruginformation.com/off_label/tables/determination_levoleucovorin.pdf


From a recent SEC filing

"FUSILEV: Starting late 2008 through early 2009, there was a disruption of leucovorin supplies. We mobilized our resources to help the oncology community address the situation. At the time, we worked with the FDA and the oncology community and were able to supply FUSILEV (levoleucovorin) to fulfill part of the shortage and benefit several thousand cancer patients. Once again, beginning in June 2010, a similar situation has occurred. We are again working with the FDA and the oncology community to supply FUSILEV and address the disruption in supplies of leucovorin, which is critical to the care and survival of cancer patients. In the long run, expansion of FUSILEV sales largely depends upon our obtaining FDA approval for use of FUSILEV in combination with 5-FU containing regimens for the treatment of colorectal cancer; and subsequent favorable reimbursement. In October 2008, we filed a supplemental New Drug Application, or sNDA for advanced metastatic colorectal cancer. In October 8, 2009, we received a Complete Response letter from the FDA regarding our sNDA. We met with the FDA in January 2010 and the FDA has requested additional data, which we plan to submit as soon as available."