10月11日，F(xiàn)DA已批準(zhǔn)過(guò)敏藥物噴鼻劑Nasacort Allergy 24HR作為一種非處方（OTC）藥物，用于2歲及以上兒童和成人，治療季節(jié)性和常年性過(guò)敏性鼻炎。在美國(guó)，Nasacort是首個(gè)也是唯一一個(gè)非處方類(lèi)過(guò)敏藥物噴鼻劑，將由賽諾菲旗下Chattem公司銷(xiāo)售。

在美國(guó)，每年有多達(dá)6000萬(wàn)人遭受季節(jié)性和常年過(guò)敏性鼻炎，該病可嚴(yán)重影響成人和兒童的生活質(zhì)量，干擾其睡眠、戶(hù)外活動(dòng)。Nasacort和同類(lèi)噴鼻劑被認(rèn)為是治療花粉癥和其他呼吸道過(guò)敏的最有效藥物。

Nasacort是唯一一種單一活性成分非處方藥，能夠緩解鼻過(guò)敏癥狀，包括鼻塞，每日單一劑量可提供24小時(shí)的緩解。

Nasacort Allergy 24HR獲批作為OTC類(lèi)藥物，是基于13個(gè)安慰劑對(duì)照藥效學(xué)研究的數(shù)據(jù)、來(lái)自43個(gè)臨床研究的安全性數(shù)據(jù)、以及Nasacort AQ上市后16年來(lái)的檢測(cè)數(shù)據(jù)。

Chattrm預(yù)計(jì)將于2014年春季將Nasacort推向市場(chǎng)。

Nasacort AQ將成為美國(guó)市場(chǎng)中首個(gè)非處方（OTC）鼻內(nèi)皮質(zhì)類(lèi)固醇激素。目前，該藥已經(jīng)在10多個(gè)國(guó)家以非處方藥物銷(xiāo)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.