Therapy Areas: AIDS & HIV
Innovus Pharma Wins FDA Approval of New ANDA for Supply of FlutiCare
23 April 2019 - - The US Food and Drug Administration has approved abbreviated new drug application No. 208024 for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray owned by Akorn, Inc. (NASDAQ: AKRX), US-based emerging commercial-stage pharmaceutical company Innovus Pharmaceuticals, Inc. (OTCQB Venture Market: INNV) said.

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 four 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 USD 343m based on certain published data.

In addition, Innovus Pharma announced that it has reached a sales milestone with its sale of at least 1,000 units of FlutiCare per day through its various sales channels.

In December 2015, Innovus Pharma acquired Novalare FP, Inc. and changed its name to Novalere, Inc. and pursuant to that transaction, the company acquired the rights to receive FlutiCare supply from Akorn following ANDA approval.

On April 17, 2019, the FDA approved the ANDA and Akorn alerted the company of the approval.

While waiting for ANDA approval, Innovus Pharma announced an alternative source of supply for its FlutiCare product through its commercial partnership with a third party supplier on May 9, 2017.

Since that time, the company has procured its supply of FlutiCare pursuant to ANDA No. 207957 through this third party supplier. Innovus Pharma currently has secured two batches of its FlutiCare product from this entity.

The company also said that it has reached an important sales milestone in the history of Innovus Pharma's sales efforts, in that it has now sold over 1,000 units of FlutiCare through its various sales channels.

On February 1, 2019, the company announced that its FlutiCare product is currently ranked #2 behind Flonase in Amazon's Fluticasone Propionate and Allergy Relief categories.

In addition, FlutiCare is currently ranked #6 in Amazon's Best Moisturizing Nasal Sprays category, #11 in the Best Allergy Medicine category and #41 in the Sinus Medicine category.

FlutiCare is a nasal spray, which provides 50 micrograms of fluticasone propionate per spray, a nasal corticosteroid that provides 24-hour temporary relief of seasonal and perennial nasal allergy symptoms. FlutiCare can be used to relieve both indoor and outdoor nasal allergy symptoms caused by pollen, dust, animal dander, and other indoor and outdoor allergens.

Nasal allergy symptoms include nasal congestion, runny nose, sneezing, itchy nose, etc.

FlutiCare contains the most prescribed nasal steroid active pharmaceutical ingredient and form for nasal allergy relief over the last seven years. FlutiCare is available OTC with the same prescription strength and same delivery method as Flonase and ClariSpray.

The company currently believes that FlutiCare is the most affordable fluticasone propionate nasal spray on the market and is now available in one dose, a 30 Day (120 Sprays) treatment and is the only one providing an monthly autoship plan.

Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the commercialisation, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men's and women's health and vitality and respiratory diseases.
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