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Shijiazhuang Sihua Pharmaceutical Group’s Fluvoxamine Maleate Tablets (50 mg) Have Been Approved
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发布时间：2025-03-03
【概要描述】
On February 28, Shijiazhuang Sihua Pharmaceutical Group’s newly formulated 50-mg fluvoxetine maleate tablets, classified as a Category 4 chemical drug, received approval for drug registration from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation. This marks the group’s eighth approved new dosage-form product so far this year, signaling a strong start to its R&D and innovation efforts.
On February 28, Shijiazhuang Sihua Pharmaceutical Group received approval from the National Medical Products Administration for a new dosage form of its Class 4 chemical drug—fluvoxamine maleate tablets (50 mg)—which is also deemed to have passed the consistency evaluation. This marks the group’s eighth newly approved formulation product so far this year, signaling a strong start to its R&D and innovation efforts.
Previously, the fluvoxamine maleate tablets (100 mg) were approved in August 2024. To date, the Group has a total of 156 product specifications across 117 varieties that have either passed or are deemed to have passed the consistency evaluation, maintaining its leading position in innovation and performance.
According to reports, fluvoxamine maleate tablets are primarily indicated for the treatment of depression and related symptoms, as well as obsessive-compulsive disorder. Currently, fluvoxamine maleate tablets are included in the National Medical Insurance Category B Reimbursement List. Data from MeneNet show that in 2023, sales of this product across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 574 million, with sales reaching RMB 318 million in the first half of 2024, reflecting strong market performance in the domestic segment.
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Non-Commercial (Filing) – 2025-0091