Innovus Pharma Announces Three Regulatory Filings with Health Canada for Its Products: Xyralid® Suppositories, Beyond Human® Testosterone and RecalMax™
Published: Aug 07, 2018
The Three Potential Products, If Approved, Will Supplement the Company’s Eight Products Launched in Canada to Date
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 the filing by it for regulatory approval in Canada for its (1) Xyralid® Suppositories drug for the relief of hemorrhoidal swelling, (2) Beyond Human® Testosterone to promote and maintain testosterone levels in men and (3) RecalMax™ for cognitive health and mental sharpness. The regulatory approval process for the three products may take anywhere up to 210 days for approval depending on the application.
“We are happy to announce our filing of applications with Health Canada for our Xyralid® Suppositories, Beyond Human® Testosterone and RecalMax™,” said Dr. Bassam Damaj, the President and Chief Executive Officer of Innovus Pharma. “We believe, if approved, these three products will sell well in Canada for their indications and will then represent the six, seventh and eighth products launched by us in Canada through our own sales and marketing commercial efforts in addition to our products ProtaGoRx™, Vesele®, Apeaz®, Xyralid® and AllerVarx™. When combined with the other four products we have launched there already through third-party distributors, including Zestra®, Zestra Glide® and Uxor® (EjectDelay®) marketed by Orimed Pharma and UriVarx® through our partnership with Acerus Pharmaceuticals Corporation, we may have in total, in the near future, twelve of our products being marketed and sold in Canada.”
About Xyralid® Suppositories
Xyralid® Suppositories was filed as an OTC drug in Canada with the indication to temporarily shrink hemorrhoidal tissue. Xyralid® Suppositories temporarily relieve itching, burning and discomfort associated with hemorrhoids and aid in protecting irritated anorectal areas.
About Beyond Human® Testosterone
Beyond Human® Testosterone is a patented product filed in Canada as a Natural Health Product with the indication to promote and maintain the levels of testosterone in men, which often decline with normal aging.
RecalMax™ is a patented formulation of L-Arginine and L-Citrulline, in combination with the natural absorption enhancer Bioperine®. RecalMax™ was filed in Canada as a Natural Health Product with the indication to increase mental health and mental sharpness. The beneficial effects of RecalMax™ on cognitive functions were confirmed in a four-month U.S. clinical survey study involving 152 patients (69 men and 83 women). Results from the clinical survey have indicated improvement in multiple brain functions, including word recall and focus.
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.
For more information, go to www.innovuspharma.com; www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.urivarx.com; www.sensumplus.com; www.myandroferti.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.recalmax.com; www.prostagorx.com; www.fluticare.com; www.allervarx.com; www.apeaz.com; www.diabasens.com; and www.xyralid.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 the potential three above products in Canada, 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.
Innovus Pharma Investor Relations
Randy Berholtz, +1-858-249-7865
Source: Innovus Pharmaceuticals, Inc.