BRIDGEWATER, N.J., Feb. 1, 2017 /PRNewswire/ -- Sanofi announced
today that the U.S. Food and Drug Administration (FDA) approved
Xyzal® Allergy 24HR as an over-the-counter (OTC)
treatment for the relief of symptoms associated with seasonal and
year-round allergies. Specifically, two formulations of Xyzal are
now approved for OTC use – 5 mg tablets for ages 6 years and
older, as well as 0.5 mg/mL oral solution for ages 2 years and
older. Xyzal is an oral antihistamine with a proven 24-hour effect.
"The FDA approval of Xyzal builds on our heritage of
successful Rx-to-OTC switches, and adds another trusted option to
our existing portfolio of OTC allergy medications," said
Robert Long, Head of North America
Consumer Healthcare, Sanofi. "We look forward to making it
available to allergy sufferers across the country, as the latest
product in our growing consumer healthcare business."
As many as 60 million Americans suffer from allergic rhinitis,
which is also commonly known as hay fever.1
Antihistamines are the most widely used medications to relieve hay
fever symptoms.2 Xyzal is an antihistamine that contains
the active ingredient levocetirizine dihydrochloride, which has a
well-established safety and efficacy profile. It offers 24-hour
relief from runny nose, sneezing, itchy watery eyes and itching of
the nose or throat, all in a single daily dose.
Sanofi Consumer Healthcare's existing allergy portfolio includes
Allegra Allergy, which was approved for OTC use in 2011 and
Nasacort Allergy 24HR, which was approved for OTC use in 2013. The
company anticipates that Xyzal will be made available in Spring
2017.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
Sanofi Forward-Looking Statements
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release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
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generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
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statements. These risks and uncertainties include among other
things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic
conditions, the impact of cost containment initiatives and
subsequent changes thereto, the average number of shares
outstanding as well as those discussed or identified in the public
filings with the SEC and the AMF made by Sanofi, including those
listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi's annual report on Form 20-F
for the year ended December 31, 2015.
Other than as required by applicable law, Sanofi does not undertake
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Contacts:
Media
Relations
|
Investor
Relations
|
Ashleigh
Koss
|
George
Grofik
|
Tel. : (908)
981-8745
|
Tel.: + (33) 1 53 77
45 45
|
ashleigh.koss@sanofi.com
|
ir@sanofi.com
|
1 American College of Allergy Asthma and Immunology
(ACAAI). Allergic Rhinitis. Available online at
http://acaai.org/allergies/types/hay-fever-rhinitis. Accessed
November 11, 2016.
2 American Academy of Allergy Asthma and Immunology
(AAAAI). Antihistamines. Available online at
https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/antihistamines.
Accessed November 11, 2016.
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SOURCE Sanofi