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FDA approves Akorn’s ANDA for fluticasone propionate nasal spray

Akorn announced that the FDA has approved an ANDA for fluticasone propionate nasal spray submitted by Hi Tech Pharmacal, which was acquired by Akorn in 2014. The nasal spray is a generic of GSK’s Flonase, which was approved for OTC sales in the US in 2014.

Akorn President and CEO Douglas Boothe said, “We are excited to add to our fluticasone franchise and look forward to expanding into the over-the-counter (OTC) market. Among other private label possibilities, we have a supply agreement in place for FlutiCare through Innovus Pharmaceuticals, Inc.”

Innovus Pharmaceuticals launched FlutiCare in the US in 2017, and the company says that it is now selling over 1,000 units per day, ranking second on Amazon for fluticasone propionate nasal sprays behind Flonase.

According to Innovus, the rights to receive a supply of FlutiCare from Akorn came along with its acquisition of Novalere in 2015. Because the ANDA for the Akorn fluticasone propionate was delayed, Innovus entered into a supply agreement with West-Ward in May 2017, allowing the company to launch FlutiCare that year.

Innovus President & CEO Bassam Damaj commented, “FlutiCare strong increase in sales on Amazon in a short period of time demonstrates the strong name recognition of our FlutiCare drug and the power of Innovus’s OTC platform. Our team has had significant success in making FlutiCare a recognized and trusted brand and one of the strongest competitors of Flonase online. Important product success in a very competitive market is what differentiates Innovus’ exceptional sales and marketing capabilities.”

Read the Akorn press release.
Read the Innovus Pharmaceuticals press release.

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published on April 19, 2019

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