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CDE plans to expedite the review of 42 new drugs, including two respiratory drugs from Health & Medicine, which are proposed for priority review.
Published Time：
2018-12-18
Among the 44 drugs that were to be included in the priority review procedure, as announced by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on June 5, 2018. 【HealthGen Biotech Group】 Wholly-owned subsidiary Shenzhen Tai Tai Pharmaceutical Co., Ltd. and its holding subsidiary Shanghai Fanyu Health Pharmaceutical Technology Co., Ltd. submitted Levosalbutamol Hydrochloride Inhalation Solution ① and the company's wholly-owned subsidiary Shenzhen Haibin Pharmaceutical Co., Ltd. submitted the application for Salmeterol Xinafoate Inhalation powder ② were both included in the list of "Announcement on the registration applications for drugs to be included in the priority review procedure (29th batch)" recently released by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
Levosalbutamol Hydrochloride Inhalation Solution ① The original research product is Sunovion's Xopenex®, which was launched in the United States in April 1999, used for the prevention and treatment of asthma and COPD. Currently, there are no levosalbutamol hydrochloride inhalation solutions on the market in China.
Salmeterol Xinafoate Inhalation powder ② The original research product is GlaxoSmithKline's Seretide®, which was first approved for import in China in 2003, used for the regular treatment of reversible obstructive airway diseases, including asthma and chronic obstructive pulmonary disease. Currently, there are no generic drugs on the market in China.
With the acceleration of the review process, the public will benefit greatly, not only with more efficient medication, but also a significant reduction in their medication burden. This is of great significance to improving the quality of development in the pharmaceutical industry and further promoting the internationalization of the pharmaceutical industry.
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