INNV Innovus Pharmaceuticals

Following Its Recent Approval from Health Canada for the Relief of Neuropathy Pain, Innovus Pharma Announces Receipt of Notification to Commercialize Diabasens® in the European Union

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 it has received the CPNP notification number required to commercialize Diabasens® in all 28 member countries of the European Union. This represents the fourth Innovus Pharma product to receive CPNP notification in the European Union in the last few years, the others being for Zestra®, Zestra Glide® and Sensum+®. The product will be available as an over-the-counter (“OTC”) or behind the counter product and does not require a prescription.

“We are pleased to announce the receipt of the CPNP in the European Union for Diabasens®, our current best-selling product. The clearance to market the product in Europe follows the recently announced approval from Health Canada for the relief of neuropathy pain,” said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. “This is one of several products we have filed in Europe which we expect to receive the notification to commercialize in the near future.”

The product will be launched initially in France, the United Kingdom, Italy, Germany and Spain through our Pan-European Amazon® store, followed by local distributors in the second half of 2019. In addition to the US, Canada and the European Union, Innovus Pharma is working with certain regulatory agencies in Japan and throughout certain countries in Latin America to obtain appropriate marketing authorizations to eventually launch the product in that country and region.

About Diabasens®

Diabasens® is a Natural Health Product approved by Health Canada for the relief of neuropathy pain. It is a proprietary formulation to increase local sensation and blood flow. The product is also commercialized in the U.S. under the cosmetic classification.

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 OTC.

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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 the sale of the Diabasens® product in the European Union, 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.

EN
28/05/2019

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