FDA Approves United Therapeutics'
sDNA for Remodulin
United Therapeutics has announced that the FDA has
approved a supplemental new drug application (sNDA)
for Remodulin (treprostinil sodium) injection. The sNDA
was filed by the company in satisfaction of the FDA's
Subpart H accelerated approval requirement for a Phase
IV post-marketing study to confirm the clinical benefit
of Remodulin. The initial approvals of both subcutaneous
and intravenous use of Remodulin were contingent upon
the company's completion of that study.
The Phase IV study, which was successfully completed
last year, involved the transition of patients from
Flolan to either Remodulin or placebo. In the trial,
13 of 14 patients randomized to Remodulin were able
to successfully transition from Flolan and complete
the study without the need to re-institute Flolan therapy,
compared to only one of eight patients randomized to
placebo.
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