華海藥業(600521.SH):製劑產品硫酸苯丙胺片獲美國FDA批准文號
格隆匯3月13日丨華海藥業(600521.SH)公佈,近日,公司收到美國食品藥品監督管理局(以下簡稱“美國FDA”)的通知,公司向美國FDA申報的硫酸苯丙胺片的新藥簡略申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。
硫酸苯丙胺片主要用於治療發作性睡病、腦炎後遺症、麻醉藥或其它中樞神經抑制藥中毒。硫酸苯丙胺片由Arbor Pharmaceuticals研發,最早於2012年上市。當前,美國境內,硫酸苯丙胺片的主要生產廠商有Amneal、Wilshire等;國內目前尚未有該劑型的產品上市銷售。2019年該藥品美國市場銷售額約3788.88萬美元(數據來源於IMS數據庫)。截至目前,公司在硫酸苯丙胺片項目上已投入研發費用約230萬元人民幣。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.