132 drugs from 72 pharmas get MFDS nod in August
Daewoong Bio tops with 7 approvals… Followed by Medica KoreaㆍHutecs Korea with 6 Diabetes treatments remain strong with 25 Empagliflozin-based drugs… 20 approvals for Celecoxib Combination
[Newsmp] After a significant drop in July, the number of Ministry of Food and Drug Safety medications has returned to its previous levels.
According to the MFDS information platform (https://nedrug.mfds.go.kr/), pharmaceutical approvals for August totaled 132, surpassing the first-half monthly average of 130.
In particular, there has been a substantial increase in diabetes medications, including SGLT-2 inhibitors and DPP-4 inhibitors.
Empagliflozin (brand name: Jardiance) secured the highest number of approvals among SGLT-2 inhibitors, with a total of 25 (including combination drugs), out of all the ingredients of approved drugs in August.
Other SGLT-2 inhibitors, Dapagliflozin (brand name: Forxiga), received 7 approvals, while DPP-4 inhibitors, Sitagliptin (brand name: Januvia) gained 8 approvals, and Vildagliptin (brand name: Galvus) was granted 6 approvals.
Apart from diabetes treatments, there were 20 approvals for an anti-inflammatory and analgesic agent Celecoxib (brand name: Celebrex) plus Angelica Gigas RootㆍChaenomelis FructusㆍSaposhnikovia RootㆍDipsaci RadixㆍAcanthopanax Root BarkㆍAchyranthes RootㆍClematis RadixㆍCinnamon BarkㆍGentianae Macrophyllae RadixㆍCnidium RhizomeㆍGastrodia Rhi (brand name: Layla), and 10 approvals were granted for allergy treatments Montelukast (brand name: Singulair) and Levocetirizine (brand name: Xyzal) combination products.
Daewoong Bio had the most approvals with 7 approvals, followed by Medica Korea and Hutecs Korea with 6 approvals each, Mother’s Pharmaceutical, Samik Pharm, and Ahn-Gook Pharmaceutical with 5 approvals each.
Daewoo Pharm, Shinpoong Pharmaceutical, Ace Bio Pharm, Il-Yang Pharmaceutical, etc. received 4 approvals each, followed by Boryung Pharmaceutical, Aprogen Pharmaceutical, Theragen Etex, DongKook Pharmaceutical, SinSin Pharmaceutical, and Hanmi Pharmaceutical with 3 approvals each.
Moreover, Celltrion Pharm, CMG Pharmaceutical, PanGen Biotech, Kyung Dong Pharmaceutical, Neo Bio Korea Pharm., Unimed Pharma, Jin Yang Pharmaceutical, and Cosmax Pharma were also approved for two drugs.