Ativan (generic name: lorazepam) injections, which had raised concerns over a supply disruption, are expected to continue to be supplied to medical sites. Current supplier Ildong Pharmaceutical (249420) will fill the gap with existing inventory, while Samjin Pharmaceutical (005500) will take over the product to continue production and supply.
The Ministry of Food and Drug Safety said on the 12th that lorazepam injections, used for sedation purposes, will continue to be supplied to medical sites given the current supplier's inventory and upcoming license modification procedures.
Lorazepam injections are used for sedation in cases of acute anxiety and tension. Earlier, concerns grew in the medical community over a supply gap after Ildong Pharmaceutical, the sole domestic supplier, announced plans to halt production. Although the government has designated Ativan as a drug subject to withdrawal prevention measures, it has repeatedly faced supply disruptions due to raw material sourcing issues and low profitability.
Medical professionals voiced strong concerns as the drug is an essential medicine with virtually no alternatives. Kim Tae-jung, a professor of critical care medicine at Seoul National University Hospital, previously noted, "Ativan is an essential drug in intensive care units where seizures frequently occur," adding, "A supply disruption could seriously hamper patient care."
The pharmaceutical industry views recently strengthened Good Manufacturing Practice (GMP) standards for sterile drugs as another factor behind the production halt. The Ministry of Food and Drug Safety tightened sterile drug GMP standards in line with Pharmaceutical Inspection Co-operation Scheme (PIC/S) criteria, with the revised standards set to apply to finished drugs from the end of this year. The industry is concerned that the growing burden of facility investment to meet the tougher standards could lead to further abandonment of essential drug production with low profitability.
Amid this situation, Samjin Pharmaceutical has recently agreed to take over the product following the completion of technology transfer procedures. Samjin plans to finalize the procedures necessary for production and supply and apply for a license modification with the Ministry of Food and Drug Safety this month.
Ildong Pharmaceutical produced additional supplies of the product in the second half of last year. The Ministry of Food and Drug Safety plans to minimize supply disruptions through Ildong's inventory until the transfer and license modification are completed.
A ministry official said, "Once Samjin Pharmaceutical's application for license modification is submitted, we will review it promptly and cooperate with related agencies, including the Ministry of Health and Welfare, to ensure smooth supply to medical sites."
