人福醫藥(600079.SH):鹽酸胍法辛緩釋片獲藥物臨牀試驗批准通知書
格隆匯2月22日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福近日收到國家藥品監督管理局核准簽發的鹽酸胍法辛緩釋片的《藥物臨牀試驗批准通知書》,經審查,2021年12月10日受理的鹽酸胍法辛緩釋片符合藥品註冊的有關要求,同意本品開展單獨或聯合中樞興奮藥用於治療注意缺陷多動障礙(ADHD)的驗證性臨牀試驗。
鹽酸胍法辛緩釋片用於兒童及青少年注意缺陷多動障礙(ADHD)的治療。宜昌人福的鹽酸胍法辛緩釋片於2020年11月獲得FDA批准,於2021年12月向國家藥品監督管理局提交了該藥品的註冊申請並獲得受理,截至目前該項目累計研發投入約為2000萬元人民幣。根據醫藥魔方數據庫顯示,鹽酸胍法辛緩釋片暫未在國內獲批上市銷售,目前四川百利藥業有限責任公司遞交了鹽酸胍法辛緩釋片的上市申請;南京海納醫藥醫藥科技股份有限公司、江蘇萬邦生化醫藥集團有限責任公司正在開展並已公示鹽酸胍法辛緩釋片的生物等效性試驗;鄭州大明藥物科技有限公司、河南中帥醫藥科技股份有限公司等公司向國家藥監局申報並獲批臨牀。
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