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The agency said the drug was "approvable" on June 3.
"In the end, we think the product clearly shows a benefit and remains approvable."
In the past, an approvable letter was seen as a sign that the drug could be approved if certain conditions were met.
Finally, he makes a recommendation based on his review as to whether the submission is approvable or not.
"Everything that is as of right is straightforward and approvable."
U.S. health authorities last year ruled that bifeprunox was not approvable.
The Company filed a response to this second approvable letter in late September 2007.
Design quality can be maintained whilst driving development costs down to low, approvable budget levels.
Companies have been receiving 'approvable letters' indicating a drug could win approval later if certain steps were taken.
The exact content of approvable letters are not disclosed.
Wyeth received an approvable letter for bazedoxifene in late April 2007.
Having board policies in place ahead of time allows boards and staff to know whether a staff plan is approvable.
"There's no way to tell from the rule what's approvable and what's not.
If, on the other hand, Erbitux alone worked as well as the combination, the drug might be approvable for use by itself.
But, aside from these observations, the presentation of the budget must be praised as being excellent and thoroughly approvable.
An approvable letter could mean issues were 'minor' or could indicate 'you have to do a whole new set of trials,' she said.
If he had, he would have suggested that Barr receive an "approvable" letter for its application.
So, although a 55% majority prefers A over every other candidate, B is elected because 100% of the voters consider him approvable.
It is the applicant's responsibility to ensure their product is approvable prior to application.
In December that year, the council said the townhouses were approvable, but again refused permission to demolish.
It is eminently approvable and perfectly in order."
• use of approved or approvable albumin as excipient.
The company declined to discuss details in the so-called not approvable letter from the Food and Drug Administration.
The Food and Drug Administration issued an approvable letter to the medical device company for its skin cancer detector.
Approvable letters generally mean a company must satisfy certain conditions before the FDA will approve its drug.