Apeloa Pharmaceutical Subsidiary's Brivaracetam Tablets Receive US FDA Approval

RegulationProduct / Tech
โดย Jiemian·USCN·Read original
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Apeloa Pharmaceutical Co., Ltd. announced that its wholly owned subsidiary Zhejiang Apeloa Jutai Pharmaceutical Co., Ltd. has received notification from the US FDA that its abbreviated new drug application for Brivaracetam Tablets has been approved. The ANDA number is 220136, with approved strengths of 25 mg, 50 mg, and 100 mg, primarily indicated for the treatment of partial-onset seizures. The manufacturer is Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. Brivaracetam Tablets are a novel antiepileptic drug and a derivative of the second-generation antiepileptic drug levetiracetam. According to relevant data, sales of Brivaracetam Tablets in the US market in 2025 were approximately 823 million US dollars. The company stated that this approval marks its qualification to sell the product in the US market, will further enhance the product's global market competitiveness, and actively expand into the US and other overseas markets. It also noted that production and sales of the product may be affected by uncertainties such as policy and market conditions.

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Apeloa Pharmaceutical Co Ltd
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US FDA approved its subsidiary's ANDA for Brivaracetam Tablets, qualifying it to sell the product in the US market.

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浙江普洛康裕制药有限公司Private▲ Positive
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The subsidiary Zhejiang Apeloa Jutai received FDA approval for its Brivaracetam Tablets ANDA, enabling US sales.

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