10月11日，FDA已批准过敏药物喷鼻剂Nasacort Allergy 24HR作为一种非处方（OTC）药物，用于2岁及以上儿童和成人，治疗季节性和常年性过敏性鼻炎。在美国，Nasacort是首个也是唯一一个非处方类过敏药物喷鼻剂，将由赛诺菲旗下Chattem公司销售。
在美国，每年有多达6000万人遭受季节性和常年过敏性鼻炎，该病可严重影响成人和儿童的生活质量，干扰其睡眠、户外活动。Nasacort和同类喷鼻剂被认为是治疗花粉症和其他呼吸道过敏的最有效药物。
Nasacort是唯一一种单一活性成分非处方药，能够缓解鼻过敏症状，包括鼻塞，每日单一剂量可提供24小时的缓解。
Nasacort Allergy 24HR获批作为OTC类药物，是基于13个安慰剂对照药效学研究的数据、来自43个临床研究的安全性数据、以及Nasacort AQ上市后16年来的检测数据。
Chattrm预计将于2014年春季将Nasacort推向市场。
Nasacort AQ将成为美国市场中首个非处方（OTC）鼻内皮质类固醇激素。目前，该药已经在10多个国家以非处方药物销售。
英文原文：FDA Approves Sanofi’s Nasacort® 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® 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 benefit 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.
