Alembic Pharmaceuticals

Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of

有限公司周三表示，其仿制药已获得美国卫生监管机构的最终批准

Brexpiprazole

布雷克西普拉zole

tablets used in treatment of

用于治疗的片剂

major depressive disorder

重度抑郁症

. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Brexpiprazole tablets of strengths 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the company said in a statement.

该公司在一份声明中表示，美国食品和药物管理局（USFDA）的批准是针对强度为0.25 mg、0.5 mg、1 mg、2 mg、3 mg和4 mg的Brexpiprazole片剂的缩写新药申请（ANDA）。

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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD),

批准的ANDA在治疗上等同于参考上市药品（RLD），

Rexulti

拒绝

tablets of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical Company, Ltd, it added.

片剂0.25毫克，0.5毫克，1毫克，2毫克，3毫克和4毫克，大大大大大大大大大大片片片片片剂有限公司的片剂，它补充说。

Brexpiprazole is an

Brexpiprazole 是

atypical antipsychotic

非典型抗精神病药物

used as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, and also used in treatment of schizophrenia in adults and pediatric patients aged 13 years and older.

用作抗抑郁药的辅助疗法，用于治疗成人重度抑郁症（MDD），也用于治疗成人和13岁及以上的儿科患者的精神分裂症。

Citing IQVIA data, Alembic said Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 2 billion for 12 months ended September 2024.

Alembic引用IQVIA数据称，截至2024年9月的12个月内，0.25 mg、0.5 mg、1 mg、2 mg、3 mg和4 mg的Brexpiprazole片剂的市场规模估计为20亿美元。

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