普利製藥(300630.SZ):射用比伐蘆定獲得美國FDA正式批准
格隆匯5月30日丨普利製藥(300630.SZ)公佈,公司於近日收到美國食品藥品監督管理局(FDA)簽發的注射用比伐蘆定仿製藥上市批准通知。
公司於2021年1月向美國食品藥品監督管理局(FDA)遞交了PIV專利(與所申請仿製藥相關的專利是無效的或仿製藥不侵權)聲明。同時,也向原研注射用比伐蘆定上市許可持有人和專利持有人發起專利挑戰。原研公司在收到通知後的45天內未發起任何對普利製藥注射用比伐蘆定專利挑戰的訴訟,即公司注射用比伐蘆定ANDA挑戰專利成功。而後,公司向FDA通報上述進展並提交注射用比伐蘆定仿製藥最終上市批准的申請。於近日,公司收到FDA的上市批准通知,這標誌着公司具備了在美國銷售注射用比伐蘆定的資格,將對公司拓展美國市場帶來積極影響。
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