Posted by notfred on April 22, 2007, at 1:52:05
In reply to Re: Goodbye 'Zelnorm' » Fivefires, posted by 10derHeart on April 10, 2007, at 22:17:41
Special Access to Zelnorm
Though the drug will no longer be widely available, patients who have no other treatment options could still get access to the drug. The FDA said it is likely to allow Novartis to continue selling Zelnorm to patients if their doctors say they have disease that does not respond to any other treatment and if the benefits of treatment with Zelnorm outweigh the risks of serious side effects. Drug access would be done through a special program.
The FDA says it has told Novartis that it's willing to consider limited reintroduction of Zelnorm at a later date if a population of patients can be identified in whom the benefits of the drug outweigh the risks.
However, before the FDA makes a decision about limited reintroduction, any proposed plan would be discussed at a public advisory committee meeting.
poster:notfred
thread:747481
URL: http://www.dr-bob.org/babble/health/20070227/msgs/752311.html