It's interesting that the FDA should approve two large batches of andas like this in such a short space of time. Statistically it would be highly unlikely for all these andas to come up for approval under a fifo basis at the same time. One must therefore conclude that some of these andas have either been held back whilst others must of course have jumped the queue so to speak to be approved like this.
The resultant impact I think will be a fierce rush by the generic companies to get the product out there to achieve some sort of profitable market presence. Almost certainly this will be achieved through heavily discounted prices. Perhaps the pressure from members of the US govt to get drug prices down is starting to show through a shift in fda approval priorities?? Or perhaps the last week is just a fluke.
Whatever is the case, in the last six days 34 anda approvals have been announced which must be some sort of record and hopefully brings us a step closer to getting our own anda approval.
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It's interesting that the FDA should approve two large batches...
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