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遵照FDA對於第四類學名藥審查管理辦法,法德藥在接獲正式審查通知後,已發出律師函通知原廠並聲明法德藥所研發Quetiapine Fumarate ER Tablets學名藥產品完全不侵犯原廠產品專利。法德藥10月13日接獲原廠AstraZeneca公司律師函通知,向美國地區法院提出對於法德藥Quetiapine Fumarate ER Tablets第四類學名藥產品專利訴訟。
法德藥專精在緩控釋產品開發領域,國內少數擁有成功開發美國學名藥產品(ANDA)、尤其是第四類學名藥經驗,除了今年已送件的抗精神病Quetiapine Fumarate ER Tablets產品外,明年尚有肌肉鬆弛劑、過動兒症等多項藥品,都是屬於挑戰原廠專利的P IV類型產品。
除了近期才正式進入藥證審查流程的抗精神病學名藥之外,法德藥於先前已正式接受藥證審查流程的降血壓(Metoprolol Succinate ER Tablet)及糖尿病(Glyburide Tablet)用藥都已進入藥證審查的最後階段,其中長效型降血壓用藥Metoprolol Succinate ER 25mg, 50mg Tablet已接獲FDA審查完結的補件通知,法德藥也完成對FDA問題的回覆,待接獲FDA最終上市核准函後,產品即可開始在美銷售,正式進入營收階段。
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