Innovus Pharma (INNV) Announces a Second Partnered United States OTC ANDA for Minoxidil 5% Foam for Men and Women.
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 Taro Pharmaceuticals U.S.A., Inc. (“Taro”), will supply Innovus Pharma, through the Company’s wholesaler, Taro’s 5% Minoxidil Foam for men and women under its approved abbreviated new drug application (“ANDA”) No. 209074 from the U.S. Food and Drug Administration (“FDA”). Innovus Pharma will launch the drug under its own trademark Regoxidine™.
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“We continue to execute on our plan to launch new OTC drugs to leverage our success with FlutiCare® and other drugs and devices we have in the United States. Regoxidine™ is just one of many new OTC drugs we are interested in commercializing in the U.S.,” said Dr. Bassam Damaj, Innovus Pharma’s President and Chief Executive Officer. “In addition to our FlutiCare® product, this Regoxidine™ product represents the second OTC ANDA product that we have launched or expect to launch in the United States. With the limited competition in this space, we believe that a great opportunity for a national brand to compete with Rogaine®* exists and we want to take advantage of it.”
“Our goal is to launch Regoxidine™ in the U.S. in the second half of this year,” added Dr. Damaj.
About Regoxidine™ 5% Minoxidil Foam for Men and Women
Regoxidine™ is a topical foam containing 5% minoxidil that is approved by the FDA as a hair regrowth treatment and is used to grow hair on the top of the scalp. The active ingredient is 5% minoxidil and is comparable to the Rogaine®* line of similar products from Johnson and Johnson. The product comes in a 60g cannister and will be sold as a 90-day supply for men and as a 120-day supply for women.
Regoxidine™ will be available as a foam for men and women.
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.xyralid.com; www.fluticare.com; www.allervarx.com; www.apeaz.com; and www.regoxidine.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 Regoxidine™, 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.
*Rogaine® is a trademark owned by Johnson and Johnson.
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