The FDA reviewed its programs for Nplate and Promacta, programs that required pharmacies, patients and doctors to receive special training and enrollments, and determined that the programs were no longer necessary in their current form for these treatments.
"The agency has concluded that the long-term safety of Nplate and Promacta can be evaluated based on ongoing clinical trials, post-approval studies agreed to by both companies, and adverse event reports submitted to FDA."
The bottom line for patients:these treatments will be easier to obtain since the time involved and number of steps will be reduced.
For more information see:
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm282502.htm
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