The National Medical Products Administration (NMPA) has suspended approval for UCB’s Keppra (levetiracetam) concentrated solution after an overseas inspection uncovered inconsistent expiration date labeling. The decision affects batches manufactured and packaged abroad, with UCB initiating a voluntary recall and cooperating to resolve the issue.
Company Response
UCB announced the recall of four specific batches of the injectable solution, stating the products are within their valid registration period and pose no safety risks. The firm is working with regulators and overseas facilities to implement corrective measures and resume supply in China.
Drug Details
Keppra, a pyrrolidone derivative developed by UCB, is used to treat partial seizures in epilepsy patients. Approved in the US in 1999 and launched in China in 2007, it is available as tablets, oral solution, and injectable solution. The injectable form is used when oral administration is not feasible.
Market Impact
The suspension only impacts the overseas-manufactured concentrated solution, Does not affect the production and supply of other specifications or UCB products. UCB won a tender in China’s third volume-based procurement (VBP) round, securing supply contracts in seven regions. Fineline Info & Tech data shows the drug is sold in multiple forms, with the injectable solution accounting for a smaller share of clinical use.-Fineline Info & Tech
