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.
As previously announced, in the United States the Company continues to work with the COG as well as external experts and advisors to gather patient follow-up data from the Phase 3 L-MTP-PE trial and to respond to other questions in the non-approvable letter the Company received from the U.
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.
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 matter relates to the failure to disclose a non-approvable letter for Pennsaid received from the US FDA in August of 2002.
The Company believes that this amendment addresses the concerns raised in the Agency's non-approvable letter of March 2006.
To address the long-term safety requirements as outlined in the Non-Approvable Letter letter, Nuvo conducted study 112E, a long-term multi-centre, single-arm safety study of Pennsaid applied by patients with symptoms of osteoarthritis of the knee.
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