FDA changes Nplate
December 8, 2011
THE US Food and Drug
Administration has modified the
requirements of the Nplate
(romiplostim) Risk Evaluation and
Mitigation Strategy Program.
As such prescribing physicians,
patients and institutions are no
longer required to enrol in the
safety monitoring program, called
the Nplate NEXUS (Network of
EXperts Understanding and
Supporting Nplate and Patients)
Program, in order to prescribe or
receive the drug.
“The goals of the Nplate NEXUS
Program were to educate
physicians and patients about
treatment risks and benefits, and
to define the long-term safety
profile of Nplate,” said Dr Roger
Executive VP of Research and
Development at Amgen.
“The FDA has now concluded
that enrolment in a restricted
distribution program is no longer
necessary,” he added, saying that
Amgen will continue to monitor
the safety profile of Nplate
through clinical trials.
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