The FDA issued a non-approvable letter
in August last year as a result of what the agency considered flaws in the clinical trial's patient population.
Daiichi Sankyo further said that the submission reflects the conclusion of a clinical study programme designed to investigate the risk profile of Injectafer following FDA's issuance of a non-approvable letter
in March 2008 with respect to the original NDA submission.
The Food and Drug Administration issued a non-approvable letter
for the company's lead candidate, antipsychotic drug iloperidone.
But Jerini has run into trouble with the FDA, which issued a non-approvable letter
on the therapy.
In August 2004, the FDA issued a non-approvable letter
, going against the panel's recommendation.
So, for the FDA to come out with a non-approvable letter
was quite unusual, given the strong agreement in favor of over-the-counter approval at every level and of the Advisory Committee.
NORDIC BUSINESS REPORT-24 June 2002-Astra-Zeneca receives non-approvable letter
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Merck spokesman Ron Rogers declined to comment on why the FDA sent the non-approvable letter
or what added information the company would provide to regulators.