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Thursday, 04/20/2017 7:55:42 PM

Thursday, April 20, 2017 7:55:42 PM

Post# of 20617
Is this true? Fluticasone Propionate has been a prescription drug (Rx) for allergic rhinitis for many, many years. The original holder of the NDA (in the Rx form) was GSK. Due to its tremendous efficacy and safety record, fluticasone propionate was cleared in 2015 to make the switch from Rx format to OTC format. GSK was the first company (being the original holder of the NDA) to manufacture, market and sell "Flonase" as an OTC product. Are we clear so far.

In subsequent months, other pharmaceutical companies also joined-in and filed applications with the FDA to manufacture and sell fluticasone propionate as an OTC product. Some notables are: Bayer, Apotex, Perrigo etc.

Innovus acquired Novalere in November 2014 along with the rights to manufacture, market and sell FlutiCare which is fluticasone propionate. It is our understanding from the evidence we have seen, that Dr. Damaj was somehow involved in selecting a large pharmaceutical company that filed the application for FlutiCare. It is now public knowledge that this large company that filed the application for FlutiCare in November 2014, was also the holder of the Rx ANDA and the manufacturer of the fluticasone propionate.

Harry what is not public knowledge is the name of the company that filed the FlutiCare ANDA application. I, however, have made a solid prediction that the name of that company is Hikma Pharmaceutical that has a U.S. based subsidiary called west-Ward Pharmaceutical. This is just my prediction based on my own research.

Hope this helps and if not, please call the FDA.

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