non-approvable letter

non-approvable letter

An official communication from the US Food & Drug Administration to a New Drug Application (NDA) sponsor, which describes significant deficiencies in the application that require correction before the application can be considered by the FDA.
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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 for Casodex (C)1994-2002 M2 COMMUNICATIONS LTD http://www.m2.com
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.
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