FDA Approves Sanofi (France)'s Nasacort® Allergy 24HR for Over-the-Counter Use
Published: Oct 11, 2013
PARIS, Oct. 11, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) approved Nasacort® 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, 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 benefit from having an additional treatment option and it's a strong addition to our existing consumer health 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.
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