- Policy
- The MFDS released the minutes of the Advisory Meeting
- by Lee, Tak-Sun Mar 2, 2021 06:25am
- The Central Pharmaceutical Affairs Review Committee, a legal advisory body of the MFDS, also found that there was a controversy over the AstraZeneca (AZ) COVID-19 vaccine, which has been delayed for vaccination for 65-year-olds. It is administered to adults over the age of 18, including those over 65, but there was an opinion that the eld
- Policy
- The MFDS is pre-reviewing a combination of Mifegyne
- by Lee, Jeong-Hwan Feb 25, 2021 06:23am
- The MFDS announced that it is in the process of applying for a preliminary review of the combination drug Mifepristone(generic for Mifegyne) and Misoprostol. The MFDS has also initiated a guideline for safe use of abortion pill and is also planning to collect opinions from experts such as gynecologists and women's groups. On the 24th,
- Policy
- Can Pfizer Vaccine be vaccinated immediately after arrival?
- by Lee, Tak-Sun Feb 24, 2021 06:03am
- 117,000 doses of Pfizer's COVID-19 vaccine supplied by the COVAX Facility will arrive in Korea on the 26th, and attention is focused on whether vaccination is possible immediately. COVAX Facility's Pfizer vaccine is highly likely to greatly simplify the assay method, as it is introduced in Korea through a special import rather than a domesti
- Policy
- IMDs for Champix are being commercialized
- by Lee, Tak-Sun Feb 24, 2021 06:02am
- IMDs of domestic pharmaceutical companies that challenge Champix (Varenicline Tartrate, Pfizer) are attracting attention. This is because film-type formulations with enhanced convenience and SR formulations are promoting commercialization. Although generic products have already been released, demand for IMDs is expected to remain high. Ac
- Policy
- Antidiabetic drug GLP-1 RA to be recommended for NASH
- by Lee, in-bok Feb 23, 2021 06:11am
- The use of antidiabetic drug is to be expanded in treating non-alcoholic steatohepatitis (NASH) as the Korean Association for the Study of the Liver (KASL) gave a priority recommendation on prescription of pioglitazone. The prospective prescription strategy is likely to see a significant change as a glucagon-like peptide 1 receptor agonist (
- Policy
- Weighted average price of α-GPC, ₩512
- by Lee, Hye-Kyung Feb 22, 2021 06:18am
- The weighted average price of Choline alfoscerate 0.4g, which was the subject of reevaluation of the adequacy of benefits last year, decreased 0.2% from the previous year to &8361;512. The weighted average price of Vitis vinifera 50mg. and Avocado-Soya unsaponifiables 0.3g, which are undergoing re-evaluation this year, decreased by 1.7% and
- Policy
- Central Committee conflicted over Rekirona limits use
- by Lee, Tak-Sun Feb 22, 2021 06:17am
- Apparently, the Central Pharmaceutical Affairs Deliberation Committee has reached a conclusion after an intense discussion in approving of Celltrion’s COVID-19 monoclonal antibody treatment Rekirona, conditionally authorized for use on Feb. 5. The Central Pharmaceutical Affairs Deliberation Committee was convened for a meeting on Jan. 2
- Policy
- Ninlaro for multiple myeloma & Lutathera are listed
- by Lee, Hye-Kyung Feb 22, 2021 06:17am
- The standard of benefit of Ninlaro (Ixazomib Citrate), combination therapy for multiple myeloma and Lutathera (Lutetium Oxodotreotide) for neuroendocrine cancer will be established. The HIRA announced that it is proceeding with the amendment of the announcement according to drugs prescribed and administered to cancer patients and will rec
- Policy
- AstraZeneca's vaccine, lot release for 780,000 people
- by Lee, Tak-Sun Feb 22, 2021 06:17am
- All administrative procedures for AstraZeneca's COVID-19 vaccine, scheduled for vaccination on the 26th, have been completed. The final step was approved by the MFDS. The MFDS announced that it had national lot release of 787,000 people (1,574,000 doses) of AstraZeneca's COVID-19 vaccine applied on the 29th of last month on Wednesday.
- Policy
- Atozet’s generics are approved
- by Lee, Tak-Sun Feb 19, 2021 06:17am
- Generics for Atozet (Ezetimibe/Atorvastatin, MSD Korea) were approved on the 18th. Dongkoo Bio, which had joined the Chong Kun Dang group, was also approved. It is reported that Dongkoo Bio transferred and acquired the existing licensed items and newly licensed generic for Atozet according to the license regulations. On the 18th, the MFDS
