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FDA批准GSK过敏药Flonase作为非处方药物(OTC)销售

  1. Flonase
  2. 丙酸氟替卡松
  3. 花粉过敏
  4. 葛兰素史克

来源:生物谷 2014-07-25 16:43

FDA批准GSK抗过敏药物Flonase作为非处方药(OTC),用于治疗花粉症或缓解上呼吸道过敏症状,该药是美国首个也是唯一一个适用于全部鼻腔和眼睛相关过敏症状的非处方(OTC)喷鼻剂。

2014年7月25日讯 /生物谷BIOON/ --葛兰素史克(GSK)7月24日宣布,FDA已批准Flonase Allergy Relief(丙酸氟替卡松50微克鼻喷雾剂)作为一种非处方药(OTC),用于治疗花粉症或暂时缓解上呼吸道过敏症状。该药是美国首个也是唯一一个适用于所有鼻腔和眼睛相关过敏症状(包括流鼻涕,打喷嚏,鼻痒,鼻塞,眼睛发痒,流泪)的非处方(OTC)喷鼻剂,每天喷一次,即可提供24小时的无犯困过敏缓解,并有助于减轻炎症。Flonase Allergy Relief于1994年获批上市作为一种处方药。目前为止,还没有任何其他药物的疗效胜过Flonase Allergy Relief。

目前,在美国大概有5000万人遭受鼻过敏,该病可导致疲劳、睡眠障碍、学习及注意力问题,并可能损害学习和工作能力。在2010年,全美过敏性鼻炎(AR)患者在医疗相关的花费约为175亿美元。

关于Flonase Allergy Relief:

目前,Flonase Allergy Relief(丙酸氟替卡松50微克鼻喷雾剂)获FDA批准在美国作为一种非处方药(OTC),该药是一种糖皮质激素类药物,具有强效的局部抗炎与抗过敏作用,用于治疗花粉症(hay fever)症状,包括:鼻塞,流鼻涕,打喷嚏,鼻痒,眼睛发痒,流泪。在英国,该药品牌名为Flixonase,作为非处方药(OTC)已有超过10年的历史,该药在其他10多个国家也作为非处方药(OTC),包括澳大利亚和中国(品牌名为辅舒良)。(生物谷Bioon.com)

英文原文:FDA approves Flonase allergy relief for sale over-the-counter in the United States

No. 1 prescribed allergy treatment ingredient1 to be available OTC

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Allergy Relief (fluticasone propionate 50 mcg spray), containing the No. 1  prescribed allergy treatment ingredient1, as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.2

Flonase® Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms3,4 including runny nose, sneezing, itchy nose5-7, nasal congestion8-11 and itchy and watery eyes.12-15 Flonase® Allergy Relief will be available at full prescription strength and to provide 24-hour non-drowsy allergy relief.

Roughly 50 million people in the United States suffer from nasal allergies16, and allergies take a toll on sufferers:

Nasal allergies can lead to fatigue, sleep disturbances, learning and attention problems and impaired function at work and/or school.17

In 2010, Americans with allergic rhinitis (AR)  spent approximately $17.5 billion on health- related costs, lost more than 6 million work and school days and made more than 16 million visits to the doctor.18

70 percent of sufferers treat their symptoms19; however, 50 percent report they are not completely satisfied with their current method of treatment.20

No other intra-nasal hay fever and allergy treatment has been proven more effective than Flonase® Allergy Relief,1,8 a once-a-day nasal spray which helps relieve inflammation to provide 24-hour non-drowsy symptom relief.21,22 Fluticasone propionate, the active ingredient in Flonase® Allergy Relief, has helped more allergy sufferers than any other nasal spray and has a well-established safety profile with 30 million accumulated patient years since it was first approved as a prescription medicine in 1994.23

Colin Mackenzie, President of Consumer Healthcare North America at GSK, said, “With the significant number of allergy sufferers in the United States and a considerable number of those unsatisfied with their current treatments, we believe the wide availability of Flonase® Allergy Relief over-the-counter is great news for these individuals. GSK has a strong heritage—40 years— in discovering and developing respiratory treatments used by patients worldwide.  We are proud of our track record of successful Rx-to-OTC switches which over the years have significantly improved access to important medicines for our consumers.”

“This approval will bring Flonase® Allergy Relief to consumers in a convenient way at the same dosage strength as found in prescription Flonase. For those with allergies, being able to find simple, effective relief over the counter may mean the difference between a day lost to allergies and a day enjoying their favorite activities,” said Dr. Vidhu Bansal-Dev, Vice President, Research and Development, GSK.Flonase® Allergy Relief will be available over-the-counter in early 2015.

About Allergies

Symptoms of nasal allergies (allergic rhinitis) include sneezing, congestion, runny nose; itchy or sore throat, post-nasal drip and cough; and red, itchy watery eyes.24 Allergy symptoms can leave sufferers feeling irritable, breathless, sleepless and fatigued.25,26

About Flonase Allergy Relief

Flonase® Allergy Relief (fluticasone propionate 50 mcg spray) is an approved over-the-counter (OTC) treatment for hay fever symptoms including nasal congestion, runny nose, sneezing, itchy nose and itchy, watery eyes in the United States.

Fluticasone propionate has been available over the counter in the UK for over 10 years under the brand name Flixonase, and subsequently as Pirinase. The product is also available over the counter in 11 other markets including Australia and in China where it is the number one corticosteroid nasal spray.

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