Innovus Pharma Announces FDA Approval of New ANDA for Supply of FlutiCare®

Company Also Reaches Sales Milestone of 1,000 Units of FlutiCare®
Sold per Day

SAN DIEGO–(BUSINESS WIRE)–Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB
Venture Market: INNV), an emerging commercial-stage pharmaceutical
company that delivers safe, innovative and effective over-the-counter medicine
and consumer care products
to improve men’s and women’s health and
respiratory diseases, today announced that 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, Inc. (“Akorn”) (NASDAQ: AKRX). Innovus
has a manufacturing and supply agreement with Akorn for the supply of

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.

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.

Second FlutiCare® ANDA

In December 2015, Innovus Pharma acquired Novalare FP, Inc. and changed
its name to Novalere, Inc. (“Novalere”) 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.

1,000 Units Per Day Sales Milestone

The Company also announced today 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.

Innovus’s President & CEO Bassam Damaj, Ph.D. stated, “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.”

“The market should expect in the future from Innovus Pharma continued
success with additional OTC drugs and a medical devices such as our
GluocoGorx® glucometer,” added Dr. Damaj.

About FlutiCare®

FlutiCare® is a nasal spray, which provides 50 micrograms of fluticasone
propionate (“USP”) 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 nasal steroid API that is physician recommended
and consumer preferred.

  • #1 form used by patients;
  • #1 nasal steroid active prescribed by physicians;
  • Familiar to patients, comfort of a known & trusted medicine;
  • Engrained in patients’ allergy management; and
  • Effective and safe.

FlutiCare® contains the most prescribed nasal steroid active
pharmaceutical ingredient (“API”) and form for nasal allergy relief over
the last 7 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.

About Innovus Pharmaceuticals, Inc.

Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer
goods and specialty pharmaceutical company engaged in the
commercialization, 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. Innovus Pharma
delivers innovative and uniquely presented and packaged health solutions
through its (a) OTC medicines and consumer and health products, which we
market directly, (b) commercial partners to primary care physicians,
urologists, gynecologists and therapists, and (c) directly to consumers
through our on-line channels, retailers and wholesalers. The Company is
dedicated to being a leader in developing and marketing new OTC and
branded Abbreviated New Drug Application (“ANDA”) products. The Company
is actively pursuing opportunities where existing prescription drugs
have recently, or are expected to, change from prescription (or Rx) to

For more information, go to www.innovuspharma.com;
and www.apeaz.com.

Innovus Pharma’s Forward-Looking Safe Harbor:

Statements under the Private Securities Litigation Reform Act, as
amended: with the exception of the historical information contained in
this release, the matters described herein contain forward-looking
statements that involve risks and uncertainties that may individually or
mutually impact the matters herein described for a variety of reasons
that are outside the control of the Company, including, but not limited
to, projected revenues from its FlutiCare® product, estimated market for
its products, and statements about achieving its other development,
growth, commercialization, financial and staffing objectives. Readers
are cautioned not to place undue reliance on these forward-looking
statements as actual results could differ materially from the
forward-looking statements contained herein. Readers are urged to read
the risk factors set forth in the Company’s most recent filing on Form
S-1, annual report on Form 10-K, subsequent quarterly reports filed on
Form 10-Q and other filings made with the SEC. Copies of these reports
are available from the SEC’s website or without charge from the Company.

*Flonase® is a registered trademark of GSK and ClariSpray® is a
registered trademark of Bayer.


Randy Berholtz
Innovus Pharma Investor Relations
Tel: +1 858
249 7865
[email protected]

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