The phrasing around removal of the two prior indications was that the FDA "has determined that the balance of benefits and risks no longer support approval of the drug for these indications."
It is unclear whether this move will address concerns of Congressional critics. Also, the agency did not provide any insight in the press release on the topic as to how they came to that conclusion; what were the calculations that went into the new risk/benefit ratio and how did they differ from when the drug got those indications on its label.
This move may raise more questions for the agency than are answered by its action.
The FDA also posted a web page on Ketek.
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