Apparently, in an echo of the split (6-4) ODAC vote, on October 5, 2009 we earlier reported -- the FDA has declined to immediately approve this new indication for Merck/Schering-Plough's PegIntron®. Instead, FDA staff sent Schering-Plough a complete response letter -- essentially, a "regulatory punch-list" of open items, before approval may be granted. Per Reuters' reporting:
. . . .The company is seeking FDA permission to sell the injectable drug for melanoma. But the agency declined to approve the new use, at least right now, instead issuing a complete response letter about remaining issues.
"Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PegIntron melanoma filing," the company said in a statement.
Schering did not say what the FDA's concerns were and company spokeswoman Mary-Francis Faraji said the drugmaker had no additional comment. . . .