SSkim, always keep your eye tightly on the thimble with the pea under it.
The FDA recently approved Dr Reddy's ANDA for over the counter (OTC) fexofenadine TABLETS. RDY already had an ANDA approved in December 2006 for prescription fexofenadine (ANDA 076502). Allegra was only recently changed to an OTC.
As we all know, Dr Reddy's history with the INJECTABLE fondaparinux is completely different to that of fexofenadine.
We know fondaparinux will be made in one of RDY's Indian plants with syringes filled in India by another party.
Do we know where fexofenadine will be made? It may be in the US. RDY have US manufacturing plants which will easier for the FDA to monitor.
How's that "for another angle"?
is this why fda delays are getting longer?, page-10
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