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信必可是阿斯利康公司创制的布地奈德和福莫特罗的固定剂量复方制剂,为一种压力定量吸入气雾剂,2014年在美国上市,用于治疗慢性阻塞性肺病和哮喘,是呼吸系统药物市场重磅级产品。然而,随着美国FDA于2015年6月发布信必可生物等效性指南草案,信必可的销售市场即将面临仿制药竞争的严峻挑战。解析信必可销售市场现状以及其生物等效性指南的出台对其销售市场冲击的预期。
The letter will be AstraZeneca’s fixed-dose combination of budesonide and formoterol, a pressure-dose inhalation aerosol, marketed in the United States in 2014 for the treatment of chronic obstructive pulmonary disease and asthma. Respiratory system market heavyweight products. However, with the release of the draft guidelines on bioequivalence by the FDA in June 2015, the letterpress marketing market is set to face the severe challenge of generic drug competition. Analyze the status of the letter will be available for sale market and the introduction of its bioequivalence guidelines on the impact of its sales market expectations.