FlutiCare™ (fluticasone propionate nasal spray). Innovus acquired the worldwide rights to market and sell the FlutiCare™ brand (fluticasone propionate nasal spray) and the related third-party manufacturing agreement for the manufacturing of FlutiCare™ from Novalere FP, Inc. in February 2015 (see Note 3). The Over-the-Counter (“OTC”) Abbreviated New Drug Application (“ANDA”) filed at the end of 2014 by the third-party manufacturer, who is currently selling the prescription version of the drug, with the U.S. Food and Drug Administration (“FDA”), subject to FDA approval, may allow us to market and sell FlutiCare™ OTC in the U.S. An ANDA is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. A prescription ANDA (“RX ANDA”) is for a generic version of a prescription pharmaceutical and an OTC ANDA is for a generic version of an OTC pharmaceutical. Due to the delay in approval of the third-party manufacturer’s OTC ANDA by the FDA, in May 2017, we announced a commercial relationship with a different third-party manufacturer (West-Ward Pharmaceuticals International Limited or “WWPIL”) who has an FDA approved OTC ANDA for fluticasone propionate nasal spray under which they have agreed to manufacture our FlutiCare™ OTC product for sale in the U.S. (see Note 9). We expect to launch our FlutiCare™ OTC product in the U.S. in the second half of 2017.
"Perfection is not attainable, but if we chase perfection we can catch
excellence." Vince Lombardi
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