approvable


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Nevro (NYSE:NVRO) revealed on Thursday the receipt of an approvable letter from the US Food and Drug Administration (FDA) for its Premarket Approval Application (PMA) for the Senza spinal cord stimulation (SCS) system.
80 m and / or standard low-about 12 m), each at least EUR 6 engine, eligible under GVFG vehicle promotion regulations of the State of Baden-WE-rttemberg from 2014 and approvable according to traffic regulations and BOKraft.
This approvable letter for DAYTRANA is positive news for Shire and our partner, Noven Pharmaceuticals," said Shire CEO Matthew Emmens.
B check, allow underwriters to take actions on approvable cases once inexorably condemned to "do time" in purgatorial pending files.
The companies say the approvable letter asks for additional data and analysis to address a number of remaining questions.
AUSTIN, Texas -- LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced that it has received an Approvable Letter from the U.
Although the company would not specify the FDA's reasons for deeming the drug not approvable, the agency had requested that Novartis submit clinical data on the liver profile of the proposed 100-mg once-daily dose studied over 12 months of therapy.
Although the company would not specify the FDA's reasons for deeming the drug not approvable, the agency had requested that it submit clinical data on the liver profile of the proposed 100-mg once-daily dose studied over 12 months of therapy.
In the July approvable letter, the FDA stated that the drug's manufacturer, Wyeth Pharmaceuticals, would have to provide more data about the potential for serious adverse cardiovascular and hepatic effects associated with the use of the desvenlafaxine for this indication, according to the company.
An approvable letter indicates that the FDA is prepared to approve the application, once conditions specified in the letter are met to the agency's satisfaction.
NEW YORK -- Sanofi-Aventis SA was dealt a setback when the Food and Drug Administration issued an approvable letter rather than full approval for a new version of the company's Ambien (zolpidem tartrate) sleeping pill.
This decision follows a number of meetings with the FDA since October 2004, when the Company received an Approvable Letter from the FDA for Riquent.