Innovus Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved abbreviated new drug application (ANDA) No. 208024 for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) owned by Akorn. Innovus has a manufacturing and supply agreement with Akorn for the supply of FlutiCare®.
Flonase® (fluticasone propionate nasal spray USP, 50 mcg per spray) is indicated for the temporary relief of hay fever and other upper respiratory allergies in adult and pediatric patients 4 years of age and older. The Company believes that combined store brand and national brand sales for Flonase® for the twelve months ending May 2016 were $343 million based on certain published data.
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