葛兰素史克向FDA提交FF单药疗法新药申请
2013-10-25 tomato 生物谷
葛兰素史克（GSK）10月23日宣布，已向FDA提交了每日一次的吸入性糖皮质激素（ICS）药物糠酸氟替卡松（fluticasone furoate，FF）的新药申请（NDA），该药通过Ellipta干粉吸入器给药。 该药NDA已提交至FDA，将FF单药疗法（100mcg和200mcg剂量）作为每日一次的吸入性干粉维持药物，作为预防性疗法，用于12岁及以上哮喘患者。 FF单药疗法在其他地区的监管
葛兰素史克（GSK）10月23日宣布，已向FDA提交了每日一次的吸入性糖皮质激素（ICS）药物糠酸氟替卡松（fluticasone furoate，FF）的新药申请（NDA），该药通过Ellipta干粉吸入器给药。
该药NDA已提交至FDA，将FF单药疗法（100mcg和200mcg剂量）作为每日一次的吸入性干粉维持药物，作为预防性疗法，用于12岁及以上哮喘患者。
FF单药疗法在其他地区的监管申请将从2014年开始，目前该药还未获任何监管批准。
英文原文：GSK announces US regulatory submission for fluticasone furoate monotherapy for asthma
Issued: Wednesday 23 October 2013, London UK
GlaxoSmithKline plc (LSE:GSK) today announced the submission of a New Drug Application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler.
The NDA has been submitted to the US Food and Drug Administration (FDA) for FF monotherapy (100mcg and 200mcg doses) as a once-daily inhaled dry powder maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
Regulatory filings for FF monotherapy are planned in other countries from 2014 onwards. FF administered using the ELLIPTA™ dry powder inhaler is an investigational medicine and is not currently approved anywhere in the world.
ELLIPTA™ is a trademark of the GlaxoSmithKline group of companies.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
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