TrueTrades, whether it was Hikma or Hi tech India who applied for the ANDA for OTC Fluticare on behalf of INNV...
Wouldn't there be a public way to find out if there was a CLR issued, because the manufacturer was denied approval, due to some sort of manufacturing deficiency that was found and not corrected on time?
I highly doubt there was any manufacturing deficiency found, because Fluticare is easy to make/compound and Hikma or Hi tech India manufacture other drugs, without issue, in fact I doubt the FDA would even want to inspect those facilities, because they are already proven.
If the FDA did an entire manufacturing plant reinspection for every new drug, or every existing drug that went OTC, that would be dumb and time consuming and expensive. (On the other hand Ho Tech India is a 3rd world country, so who knows...)
Also, if GSK sued with a patent infringement challenge, wouldn't that be available to find as a matter of public record?
I doubt GSK or Bayer or any of them would sue with a patent infringement challenge, but I guess it is possible, they have probably done that several times in the past with other drugs.
Like I said earlier, in INNVs latest presentation the ANDA for OTC Fluticare was still noted on a slide, so it should/could still happen.
