華森製藥(002907.SZ):鹽酸丁螺環酮片獲得美國FDA新增生產場地批准
格隆匯10月10日丨華森製藥(002907.SZ)公佈,公司於近日收到了美國食品藥品監督管理局簽發的關於鹽酸丁螺環酮片(ANDA#208972)新增藥品生產場地的PAS(Prior Approval Supplement)批准的通知。
鹽酸丁螺環酮片主要適用於焦慮症的管理或焦慮症狀的短期緩解,屬於國家基藥、國家醫保藥物,為芳香族哌嗪類抗焦慮藥,是一種5-HT1A受體激動劑,治療廣泛性焦慮症和其他焦慮性障礙。其機制為選擇性作用於5-HT1A受體,通過下調5-HT功能而起到抗焦慮作用。因其特異性高,且無明顯鎮靜、催眠、肌肉鬆弛以及引起依賴或戒斷反應等不良反應,目前已廣泛適用於精神科各種焦慮症的治療,亦可用於治療軀體疾病伴發的焦慮狀態,被中外焦慮障礙治療指南均推薦為一線治療藥物。建議初始劑量為每天15mg(每天2次,每次7.5mg)。為了獲得最佳治療效果,可根據需要每隔2-3天增加5mg/日的劑量。每日最大劑量不應超過60mg。在允許劑量調整的臨牀試驗中,通常採用每天20mg-30mg的劑量,分次服用。具體藥物使用請遵醫囑。
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