多瑞醫藥(301075.SZ):鹽酸文拉法辛緩釋膠囊上市申請獲受理
格隆匯12月30日丨多瑞醫藥(301075.SZ)公佈,公司近日獲悉全資子公司湖北多瑞藥業有限公司收到國家藥監局下發的鹽酸文拉法辛緩釋膠囊藥品註冊受理通知書,國家藥監局根據《中華人民共和國行政許可法》第三十二條的規定,對上述藥品的藥品註冊申請進行了審查,決定予以受理。
文拉法辛由美國惠氏WYETH PHARMS INC(現與輝瑞合併)開發,用於治療抑鬱症(包括伴有焦慮的抑鬱症)及廣泛性焦慮障礙。最初開發的劑型為常釋片,1993年9月首先在新西蘭獲批上市,同年12月在美國獲批上市。
為提高患者用藥的依從性,惠氏又開發了每天給藥1次的緩釋膠囊。鹽酸文拉法辛緩釋膠囊於1997年首次在瑞士上市,同年10月在美國獲批,2015年9月在日本獲批,2000年進口我國,目前已在90多個國家和地區上市。
截至2021年12月鹽酸文拉法辛緩釋膠囊共有6家申報一致性評價,其中通過2家,在審評審批狀態4家。根據米內網重點城市公立醫院化藥數據庫顯示:2020年神經系統-抗抑鬱藥銷售額共17.2875億元,其中鹽酸文拉法辛緩釋膠囊1.3921億元,品牌排名前三分別為:輝瑞、北京福元、海南合瑞,市場份額分別為95%、4.94%和0.05%。(數據來源:米內網)
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