86 empagliflozin medications… 20 celecoxib combinations
[Newsmp] The number of drug approvals in South Korea increased slightly in the third quarter, after a sharp decline from 471 in the first quarter to 313 in the second quarter.
According to the Ministry of Food and Drug Safety (MFDS) information platform (https://nedrug.mfds.go.kr/), a total of 132 companies received approval from the Korean MFDS for 344 drugs (including biologics) in the third quarter.
Daewoong Bio received the most approvals, with 10, followed by Jin Yang Pharmaceutical and Hutecs Korea, with 9 each.
In addition to the top three companies, Daewon Pharmaceutical, DongKoo Bio & Pharma, Samjin Pharmaceutical, Il-Yang Pharmaceutical, Daewoo Pharm, Medica Korea, Myungmoon Pharmaceutical, Celltrion Pharm, Ahn-Gook Pharmaceutical, and Aprogen Pharmaceutical received approval for 6 drugs.
CMG Pharmaceutical, GUJU Pharm, Mother's Pharmaceutical, Binex, Samik Pharm, SamChunDang Pharm, Sinil Pharmaceutical, and Ace Bio Pharm were also approved for five items each.
Furthermore, K inno.N, JW Pharmaceutical, Kyung Dong Pharmaceutical, Nova M Healthcare, DAE HWA Pharmaceutical, DongKook Pharmaceutical, Boryung Pharmaceutical, SinSin Pharmaceutical, Shinpoong Pharmaceutical, RPBio, Jeil Pharmaceutical, Theragen Etex, PharmGen Science, Hana Pharm, and Janssen Korea obtained approvals for 4 items.
JW Shinyak, Kwang Dong Pharmaceutical, Nexpharm Korea, Daehan New Pharm, Dong Wha Pharm, Mcnulty Pharmaceutical, Medixpharm, Samsung Pharmaceutical, Samoh Pharm, Celltrion, IMCD Korea, Aju Pharm, L-Capsule, Young Poong Pharmaceutical, Withus Pharmaceutical, Chong Kun Dang Pharmaceutical, Tai Guk Pharm, and Hanmi Pharmaceutical received approval for three items each, resulting in 54 companies receiving approval for an average of more than one item per month.
Empagliflozin (brand name: Jardiance, Boehringer Ingelheim) was the most approved ingredient in the third quarter of 2023, with 86 items, accounting for one-fourth of all approved items.
Celecoxib (brand name: Celebrex, Viatris) combination products were the second most approved, with 20 items, while sitagliptin (brand name: Januvia) and rosuvastatin (brand name: Crestor, AstraZeneca) were each approved for 16 and 13 items.
Montelukast (brand name: Singulair, Organon) and levocetirizine (brand name: Xyzal, UCB) combination products, along with acetaminophen (brand name: Tylenol, Janssen), were each approved for 12 items.
Moreover, amlodipine (brand name: Norvasc, Viatris) and dapagliflozin (brand name: Forxiga, AstraZeneca) received approvals for more than 10 items.
