FDA Approves Sanofi’s Nasacort® Allergy 24HR for Over-the-Counter Use

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 
                             Allergies - 
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. 
About Sanofi
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
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
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potential, and statements regarding future performance. Forward-looking 
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"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, the Group's 
ability to bene fit from external growth opportunities, trends in exchange 
rates and prevailing interest rates, the impact of cost containment policies 
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, 2012. Other than as 
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements. 
Contacts: 
Corporate Media Relations       Investor Relations
Jack Cox                        Sébastien Martel
Tel.: +33 1 53 77 94 74         Tel.: + 33 1 53 77 45 45
jack.cox@sanofi.com             ir@sanofi.com 
Lori Lukus                      George Grofik
Tel: 908-981-3876               Tel: 908-981-6031
Lori.Lukus@sanofi.com           George.Grofik@sanofi.com 
                  
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-0- Oct/14/2013 06:35 GMT