My understanding is the drug is still approved......as long as it is made the way it was two years ago (October 2011) when DSCO last submitted their NDA and the FDA approved in March 2012.
But, after that approval, DSCO didn't want to make it that way.
They said they found it needed "improvements" to the quality specs which would require further changes to the product specs. The FDA is now reviewing those potential changes to the quality and production specs requested by DSCO.
So, DSCO has several things that must be approved, in sequence, by the FDA. They must ALL be agreed to. A failure to prove their point in any one collapses all the rest.
First, that the FDA was wrong in Feb 2012 and the drug should not have been approved... because the quality and production data submitted by DSCO was faulty and/or incomplete.Apparently errors or inconsistencies arose between pre-approval batches and full scale production batches. Ooops.
Second, that the requested quality changes will remove these errors or inconsistencies.
Third, that the changes to the product are necessitated by the above quality changes.
Fourth, that the changes to the product specs do not change the drug sufficiently to require new testing. A question that has already been raised by the FDA twice since the 2003 drug trials. Now a third time.
A "No" to any one of the above and DSCO is either stuck doing it the October 2011 way... or not at all.
Still think it's a slam dunk?