The Ministry of Food and Drug Safety (MFDS) approved 118 medical products in December; 92 were manufactured and 26 were imported.

As a result, the cumulative number of medical products approved in 2023 totaled 1,823, the ministry said in its report on the status of medical product approvals for December released on Friday.

Among new drugs approved were two doses (50 mg and 150 mg) of Tukysa Tablets (tucatinib), a breast cancer treatment; Tezspire Auto-injector Injection (tezepelumab) and Tezspire Prefilled Syringe Injection, a severe asthma treatment; and Pivlaz Injection (clazosentan disodium), which prevents cerebral vasospasm and related symptoms after treatment of aneurysmal subarachnoid hemorrhage.

In addition, the regulator gave a nod to the orphan drug Columbi Injection (glofitamab) for treating diffuse large B-cell lymphoma (DLBCL).

Besides, the ministry approved FreeStyle Livre 2 (Personal Continuous Glucose Monitoring System Abbott in product name), a medical device that continuously measures glucose concentration in the interstitial fluid of cells by attaching a glucose sensor to the skin of a diabetic patient.

Details of the approvals for each medical product can be found in the electronic petition system.

"We will continue to actively discover, disclose, and provide information of high public interest by, for instance, providing the status of medical product approvals regularly, and continue to expand patient treatment opportunities by quickly approving safe and effective products based on government innovation," the MFDS said.