not-approvable letter

not-approvable letter

An official communication from the FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval of the drug or device unless corrected.
References in periodicals archive ?
Food and Drug Administration (FDA) issued on April 25, 2008 a not-approvable letter for the proposed fixed-dose combination of loratadine and montelukast.
To conduct this review, GAO examined FDA's actions prior to the May 6, 2004, not-approvable letter for the initial application.
The Amendment also includes revised, informative and transparent labeling for physicians and patients and a formal response to FDA's not-approvable letter.
On October 20, 2003, POZEN announced that it had received a not-approvable letter from the U.
FDA's not-approvable letter stated that, 'absent additional information,' our PMA-S must be considered not-approvable.
Food and Drug Administration (FDA) issued a not-approvable letter on Friday, May 28, 2004 concerning the New Drug Application (NDA) for MT 100(TM) for the acute treatment of migraine.
FDA's not-approvable letter stated that 'absent additional information' our PMA-S must be considered not- approvable.
Xcel) announced today that POZEN received a not-approvable letter from the U.
All of the reasons cited in yesterday's not-approvable letter were addressed at the Panel meeting on June 15 prior to the Panel's vote recommending approval.
NASDAQ:CRIS) today reported an announcement from Stryker Corporation in which Stryker reported that it received a Not-Approvable Letter from the U.
The blow to the Company occurred on October 20, 2003, when POZEN announced that it had received a not-approvable letter from the U.