ANI Pharmaceuticals, Inc.（简称ANI Pharmaceuticals）近日宣布，其研发的匹莫齐特（Pimozide）片剂已获得美国食品药品监督管理局（FDA）的正式批准，并即将投入市场。值得关注的是，该药品将享有为期180天的竞争性仿制药（Competitive Generic Therapy，CGT）专营权。
此次获批的匹莫齐特片剂主要用于治疗图雷特综合征等运动障碍性疾病。180天的CGT专营权意味着，在此期间FDA将不会批准其他仿制药企业生产的相同剂型和规格的匹莫齐特产品上市，这为ANI Pharmaceuticals提供了重要的市场先发优势。
公司表示，这一里程碑式的进展将进一步丰富其中枢神经系统疾病治疗产品线，同时也体现了公司在仿制药研发领域的专业实力。匹莫齐特片剂的上市将为患者提供更多治疗选择，并有望为公司带来新的业绩增长点。
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