New Drug Approval Review in the New Year 'Smooth Sailing'... 16 Product Reports Released in January

[Asia Economy Reporter Lee Gwan-ju] During the first month of the new year, approval review results (approval reports) for 16 new drugs were disclosed. While multinational pharmaceutical companies led the new drug approvals, there were also notable products.

According to the Ministry of Food and Drug Safety on the 7th, a total of 54 products, including pharmaceuticals and quasi-drugs, had their approval reports disclosed in January. By category, there were 16 new drugs, 35 data-submission drugs, and 3 quasi-drugs. Notably, 81 new drug products were disclosed last year, so the fact that January alone accounts for about 20% of last year's total stands out.

Pfizer antibiotic Zavicefta.
Photo by Pfizer

Approvals were also granted for notable new drugs. Representative among them is Korea Pfizer’s next-generation antibiotic 'Xaviceftaz 2g/0.5g (Ceftazidime, Avibactam)'. This drug is a combination of the already used cephalosporin antibiotic 'Ceftazidime' and the newly developed beta-lactamase inhibitor 'Avibactam'. Its main indications include treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired pneumonia in adult patients.

Korea Janssen’s 'Valbesa Tablets', a rare drug for treating urothelial carcinoma, also received approval. Urothelial carcinoma is a cancer occurring in the epithelium (surface) of the urinary tract, mostly in the bladder but sometimes in the renal pelvis or ureter. This drug is a fibroblast growth factor receptor (FGFR) inhibitor used for patients whose disease has progressed despite prior chemotherapy and other treatments.

Korea Takeda Pharmaceutical’s post-transplant cytomegalovirus infection treatment 'Livtensity Tablets' also obtained approval. Cytomegalovirus remains latent and asymptomatic after infection but can reactivate and cause serious diseases when immunity is suppressed, such as after organ transplantation. This oral antiviral drug inhibits viral replication by reducing the activity of protein kinases involved in cytomegalovirus replication and proliferation.

Among quasi-drugs, LG Household & Health Care’s toothpaste 'Whitening Essentials Original', containing the 'new substance' (sodium metaphosphate), had its approval report disclosed. The Ministry of Food and Drug Safety classifies substances or substance groups that have no prior usage experience as active ingredients in pharmaceuticals or quasi-drugs domestically as new substances. Sodium metaphosphate is known as an ingredient that coats and protects the tooth surface.

A Ministry of Food and Drug Safety official stated, "We will continue to disclose approval review results for pharmaceuticals and quasi-drugs and provide monthly disclosure lists to support product research and development in the pharmaceutical industry." Detailed approval review results can be found on the Ministry of Food and Drug Safety’s 'Drug Safety Korea' website.

This content was produced with the assistance of AI translation services.