Concerns Over Ativan Injection Supply Eased as Samjin Pharmaceutical Takes Over Production
The Ministry of Food and Drug Safety to Expedite Drug Change Approval
for Continuous Supply
Samjin Pharmaceutical will soon begin manufacturing and supplying 'Ativan' (ingredient name: lorazepam) injection, which had previously raised concerns over potential supply disruptions.
The Ministry of Food and Drug Safety announced on May 12 that lorazepam, which is used for sedation in cases of acute anxiety and tension, will continue to be supplied to medical institutions. Samjin Pharmaceutical, which has decided to acquire the production of lorazepam, is expected to complete the necessary procedures for production and supply of the product and apply for a drug license change within this month. The ministry plans to review the application swiftly.
This medication is a benzodiazepine-class anticonvulsant that suppresses excessive neural excitation in the brain to quickly control seizures. It is one of the first-line treatments administered in emergency rooms when pediatric acute convulsions or epileptic seizures occur. The medical community considers that there is, in fact, no alternative product that can fully replace Ativan injection.
Previously, Ildong Pharmaceutical was the only company in Korea producing lorazepam domestically, but in January last year, it reported to the Ministry of Food and Drug Safety its decision to halt supply due to decreased profitability and aging facilities. Since then, the ministry and Ildong Pharmaceutical have engaged in discussions with several pharmaceutical companies to change manufacturers and transfer the product, and recently completed procedures such as technology transfer to Samjin Pharmaceutical.
The Ministry of Food and Drug Safety explained that Ildong Pharmaceutical had produced additional products in the second half of last year, and ensured that the supply of medication would continue without interruption until the product transfer and license change were completed.
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An official from the Ministry of Food and Drug Safety stated, "When Samjin Pharmaceutical submits its application for the drug license change, we will review it promptly," and added, "We will actively cooperate with the Ministry of Health and Welfare and other relevant agencies to ensure a smooth supply to the medical field thereafter."
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