Sanofi's Xyzal® Allergy 24HR Approved for Over-the-Counter Use in the United States
(Thomson Reuters ONE) -
Sanofi's Xyzal(®) Allergy 24HR Approved for Over-the-Counter Use in the United
States
Paris, France - February 1, 2017 - 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
This press 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 facts. These statements include
projections and estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are
generally identified by the words "expects", "anticipates", "believes",
"intends", "estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties, many
of which are difficult to predict and generally beyond the control of Sanofi,
that could cause actual results and developments to differ materially from those
expressed in, or implied or projected by, the forward-looking information and
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 any obligation to update or revise any forward-looking
information or statements.
Contacts:
Media Relations Investor Relations
Ashleigh Koss George Grofik
Tel. : (908) 981-8745 Tel.: + (33) 1 53 77 45 45
ashleigh.koss(at)sanofi.com ir(at)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.
Press release (PDF):
http://hugin.info/152918/R/2074857/780063.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 01.02.2017 - 07:30 Uhr
Sprache: Deutsch
News-ID 521147
Anzahl Zeichen: 6892
contact information:
Town:
PARIS
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 370 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Sanofi's Xyzal® Allergy 24HR Approved for Over-the-Counter Use in the United States"
steht unter der journalistisch-redaktionellen Verantwortung von
Sanofi (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
