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.
References in periodicals archive ?
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.
NORDIC BUSINESS REPORT-24 June 2002-Astra-Zeneca receives non-approvable letter for Casodex (C)1994-2002 M2 COMMUNICATIONS LTD http://www.
The approval process for Multaq was not exactly smooth sailing with the company receiving a non-approvable letter from the FDA for its initial new drug application (NDA) filing in 2006.
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.
OTC:IPXL) today announced that it has received a non-approvable letter from the U.
Food and Drug Administration (FDA) issued a non-approvable letter in response to the Company's New Drug Application (NDA) for ARCOXIA([R]) (etoricoxib) for the symptomatic treatment of osteoarthritis (OA).
The Company believes that this amendment addresses the concerns raised in the Agency's non-approvable letter of March 2006.
On June 13, 2005, when Connetics received an FDA non-approvable letter for Velac, the Company's stock price plummeted 27%, falling from $20.
Full browser ?