Replies to post #5396 on Innovus Pharmaceuticals Inc. (fka INNV)

[s_Henderson]

Reading past all the bickering I saw 2 significant
things. Multiple people say Fluticare is imminant.
Which could be true unless further review is
needed which one poster said it had been sent
back by FDA for more study. THAT is significant!
Has the FDA asked for more to study or are we
just waiting for approval?

Nobody said anything had been sent back by the FDA for more study!

And what kind of study are you referring to anyway? Fluticasone proprionate has completed clinical trials decades ago!! All that FlutiCare has to demonstrate is bioequivalence to the original product. Since FlutiCare is equivalent to a generic fluticasone spray that has itself already passed the ANDA process years ago (for prescription), I can't see how the ANDA could be denied.