景峯醫藥(000908.SZ):鹽酸林可黴素注射液獲得美國ANDA批准文號
格隆匯 3 月 14日丨景峯醫藥(000908.SZ)公佈,近日,公司控股子公司Praxgen Pharmaceuticals LLC (原Sungen Pharma, LLC, “Praxgen”)收到美國食品藥品監督管理局(即美國FDA)的通知,Praxgen 向美國FDA申報的鹽酸林可黴素注射液的簡略新藥申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。
審批主要結論:已經確定多劑量鹽酸林可黴素注射液3000mg/10mL (300mg/mL)的簡略新藥同原研參比製劑是生物等效的,因此治療等效於輝瑞公司(Pfizer Inc.)已上市的鹽酸林可黴素注射液(Lincocin Injection)原研(RLD)產品的規格3000mg/10mL (300mg/mL)。
鹽酸林可黴素注射液可用於敏感葡萄球菌屬、鏈球菌屬、肺炎鏈球菌及厭氧菌所致的呼吸道感染、皮膚軟組織感染、女性生殖道感染、盆腔感染及腹腔感染等,後兩種病種可根據情況單用鹽酸林可黴素注射液或與其他抗菌藥聯合應用。此外有應用青黴素指徵的患者,如患者對青黴素過敏或不宜用青黴素者,鹽酸林可黴素注射液可用作替代藥物。
鹽酸林可黴素注射液作為多劑量無菌注射劑,其研發、生產壁壘較高。目前在美國市場銷售的除了原研藥生產商輝瑞公司外,仿製藥生產商只有XGEN PHARMACEUTICALS DJB INC一家。根據IMS數據顯示,鹽酸林可黴素注射液2018年在美國市場的銷售額為1600萬美元,由於疫情及美國仿製藥大環境影響,2020年銷售額下降至240萬美元。
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