PR Newswire/Les Echos/
FDA Approves Sanofi's Nasacort(r) Allergy 24HR for Over-the-Counter Use
- Nasal Spray Treats Adults and Children with Seasonal and Year-Round Nasal
Paris, France, October 11, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY)
announced today that the U.S. Food and Drug Administration (FDA) approved
Nasacort(r) Allergy 24HR nasal spray as an over-the-counter (OTC) treatment for
seasonal and year-round nasal allergies in adults and children 2 years of age
and older. Nasacort is the first and only medicine in its class to be available
without a prescription and will be marketed by Sanofi's consumer healthcare
division in the United States, Chattem, Inc.
"We believe there is significant value in making certain types of medicines,
like Nasacort, directly available to consumers," said Anne Whitaker, President,
North America Pharmaceuticals, Sanofi US. "Allergy sufferers will bene fit from
having an additional treatment option and it is a strong addition to our
existing consumer healthcare portfolio."
Up to 60 million Americans suffer from seasonal and year-round nasal allergies
annually. This can have a major disruption to the quality of life of both
adults and children, interfering with sleep, outdoor activities, and for
children their performance at school. Nasacort and nasal sprays in the same
medication class are considered the most effective treatment for hay fever and
other upper respiratory allergies
"By adding Nasacort to Chattem's growing consumer healthcare portfolio, we are
expanding our successful OTC allergy offering that includes the Allegra family
of products," said Zan Guerry, Chief Executive Officer, Chattem.
Nasacort is the only single active ingredient OTC medicine that relieves the
full range of nasal allergy symptoms, including nasal congestion, for 24 hours
with a single daily dose.
The FDA approval of Nasacort Allergy 24HR as an OTC treatment was based on data
submitted from 13 placebo-controlled efficacy studies, and safety information
from 43 clinical studies, as well as information from 16 years of
post-marketing surveillance data for Nasacort AQ.
Chattem anticipates that Nasacort will be available in Spring 2014.
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi is the holding company of a consolidated group of subsidiaries and
operates in the United States as Sanofi US, also referred to as sanofi-aventis
U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us
or call 1-800-981-2491.
Forward Looking Statements
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Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
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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, 2012. Other than as
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Corporate Media Relations Investor Relations
Jack Cox Sébastien Martel
Tel.: +33 1 53 77 94 74 Tel.: + 33 1 53 77 45 45
Lori Lukus George Grofik
Tel: 908-981-3876 Tel: 908-981-6031
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-0- Oct/14/2013 06:35 GMT
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