Sonoma Pharmaceuticals Announces Second FDA Approval to Add Antimicrobial Language to Alevicyn™ Gel Products for Management...
December 05 2017 - 6:05AM
Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA, warrants SNOAW), a
specialty pharmaceutical company that develops and markets unique
and effective solutions for the treatment of dermatological
conditions and advanced tissue care, today announced that the U.S.
Food and Drug Administration (FDA) has approved an expanded
antimicrobial claim for the company’s key dermatology gel product,
Alevicyn™ SG Antipruritic Spray Gel, reflecting the product’s
widening clinical utility.
“With this second FDA approval now in hand, we’re pleased that
both the Alevicyn Dermal Spray solution and gel products for the
management of atopic dermatitis or eczema have expanded claims to
include antimicrobial language and data demonstrating effectiveness
against clinically relevant organisms,” said Jeff Day, president of
Sonoma Pharmaceuticals’ dermatology division, IntraDerm
Pharmaceuticals. “Our family of Alevicyn dermatology products can
be prescribed with the confidence they are simultaneously safe,
antimicrobial and efficacious in the management of various
inflammatory skin dermatoses including atopic dermatitis and
eczema.”
The first regulatory clearance to expand label language with
antimicrobial claims was issued in November by the FDA for the
Alevicyn Dermal Spray.
Alevicyn products, available via prescription, provide
dermatologists with a safe and clinically proven approach
to management of many inflammatory skin diseases, including
atopic dermatitis—without the side effects of topical steroids and
resistance issues associated with the overuse of antibiotics. In
addition, the Alevicyn family of products are being used in
both pre- and post-procedures, including skin cancer
procedures. Over the last three years, there have been over
61,000 prescriptions filled for the Alevicyn family of products,
valued at over $7.5 million. For more information
visit www.alevicyn.com.
About the Global Dermatology MarketAccording to
BCC Research, skin conditions are among the most common health
problems in most national populations, collectively exceeding the
prevalence of conditions such as obesity, hypertension and cancer.
The considerable costs of skin diseases include physician visits,
hospital care, prescription drugs and over-the-counter products for
treating or managing these conditions, as well as indirect costs
due to productivity losses.
The global market for skin disease treatment technologies is
estimated to reach $20.4 billion in 2020. The U.S. market is the
largest segment and should reach $8.6 billion in 2020.
About Sonoma Pharmaceuticals, Inc.Sonoma is a
specialty pharmaceutical company that develops and markets unique
and effective solutions for the treatment of dermatological
conditions and advanced tissue care. The company’s
products, which are sold throughout the United States and
internationally, have improved outcomes for more than five million
patients globally by reducing infections, itch, pain, scarring
and harmful inflammatory responses. The company's headquarters are
in Petaluma, California, with manufacturing operations in the
United States and Latin America. European marketing and sales
are headquartered in Roermond, Netherlands. More information can be
found at www.sonomapharma.com.
Forward-Looking StatementsExcept for historical
information herein, matters set forth in this press release
are forward-looking within the meaning of the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995,
including statements about the commercial and technology progress
and future financial performance of Sonoma Pharmaceuticals,
Inc. and its subsidiaries (the “Company”). These forward-looking
statements are identified by the use of words such as “believe,”
“achieve,” and “strive,” among others. Forward-looking statements
in this press release are subject to certain risks and
uncertainties inherent in the Company’s business that could cause
actual results to vary, including such risks
that regulatory clinical and guideline developments may
change, scientific data may not be sufficient to meet
regulatory standards or receipt of required regulatory clearances
or approvals, clinical results may not be replicated in actual
patient settings, protection offered by the
Company’s patents and patent applications may be challenged,
invalidated or circumvented by its competitors, the available
market for the Company’s products will not be as
large as expected, the Company’s products will not be able to
penetrate one or more targeted markets, revenues will not be
sufficient to fund further development and clinical studies,
as well as uncertainties relative to varying product formulations
and a multitude of diverse regulatory and marketing requirements in
different countries and municipalities, and other risks detailed
from time to time in the Company’s filings with the Securities and
Exchange Commission. The Company disclaims any obligation to update
these forward-looking statements, except as required by law.
Sonoma®, Alevicyn™ and Microcyn® Technology are trademarks or
registered trademarks of Sonoma Pharmaceuticals, Inc. All other
trademarks and service marks are the property of their respective
owners.
Media and Investor
Contact:
Sonoma Pharmaceuticals,
Inc.
Dan McFaddenVP of Public and Investor Relations(425)
753-2105dmcfadden@Sonomapharma.com
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