Shanghai Pharma gets US FDA approval for eslicarbazepine acetate

Shanghai Pharmaceuticals Holding Co. announced its subsidiary, Shanghai SPH Central China Pharmaceutical Co., received US FDA approval for its abbreviated new drug application for eslicarbazepine acetate tablets (200mg, 400mg, 600mg, 800mg). This medication treats partial-onset seizures in patients aged four years and older, with Shanghai Pharma investing approximately CNY 15.9371 million in its development.

In a separate announcement, Shanghai Pharma’s subsidiary, Shanghai SPH New Asia Pharmaceutical Co., confirmed its cefuroxime sodium for injection (0.75g) and aztreonam for injection (0.5g, 1.0g) passed China’s generic drug consistency evaluation. These approvals are expected to enhance market share and competitiveness for SPH New Asia.

The US market for eslicarbazepine acetate, including both originator and generic versions, had sales of approximately $382 million in 2024. The approval for SPH Central China expands the company's presence in the US market.