Innovus Pharma Announces a Second Partnered United States OTC ANDA for Minoxidil 5% Foam for Men and Women
May 8, 2019This New Drug will be Launched under the Tradename Regoxidine™
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 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™.
“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.
Contacts
Randy Berholtz
Innovus Pharma Investor Relations
Tel: +1 858
249 7865
[email protected]