- Policy
- MFDS added blood clots to the precautions for AZ vaccine
- by Lee, Tak-Sun Apr 29, 2021 07:21am
- A specific thrombosis with thrombocytopenia was added to the precautions for using the AstraZeneca COVID-19 vaccine. For this adverse reaction, the MFDS also recognized the causality with the vaccine. The MFDS announced on the 27th that it changed the precautions for use after consulting experts on the case of blood clots that occurred aft
- Policy
- NDMA was detected again in Nizatidine
- by Lee, Tak-Sun Apr 29, 2021 06:10am
- NDMA (N-nitrosodimethylamine), a carcinogenic substance, was detected again. There is a possibility that the number of NDMA detection items will increase in self-test. The MFDS announced on the 27th that a business operator will recover some of the manufacturing numbers of four items, including Korea Pharma's Nizatide, Nexpharm Korea's Nit
- Policy
- Six more Arcoxia generics acquire generic exclusivity
- by Lee, Tak-Sun Apr 29, 2021 06:09am
- Six generic products of Arcoxia that received belated approval acquired generic exclusivity. Other Arcoxia generics that were previously approved will go on sale next month. On the 27th, the Ministry of Food and Drug Safety approved the generic etoricoxib products of 6 pharmaceutical companies - Theragen Etex, Guju Pham, Union Korea Pha
- Policy
- AZ vaccine vaccination is being reviewed in the 2nd quarter
- by Kim, Jung-Ju Apr 29, 2021 06:09am
- The quarantine authorities are considering expanding the age range for AstraZeneca COVID-19 vaccine. Although it is currently impossible to select a product, it will be reviewed after sufficiently diversifying the quantity while changing the inoculation institution for each product characteristic in the future. Thr KCDA Commissioner Jeong Eu
- Policy
- First retinoid acne treatment in 20 years comes to Korea
- by Lee, Tak-Sun Apr 28, 2021 05:17pm
- Galderma’s Aklief cream (trifaortene), the first new retinoid molecule to receive U.S. FDA approval for the topical treatment of acne in more than 20 years, has finally set foot in Korea. On the 27th, the Ministry of Food and Drug Safety (MFDS) approved Galderma Korea’s ‘Aklief cream 0.005%’ as a new drug. The new drug is indicated f
- Policy
- The government signed an additional 40 million doses
- by Kim, Jung-Ju Apr 28, 2021 06:05am
- The government has signed an additional 40 million doses of Pfizer's COVID-19 vaccine product. As a result, Korea has secured twice the amount of vaccine vaccination in the country, enabling it to achieve the goal of forming collective immunity in November. Pan-government vaccine introduction TF (Team Leader Kwon Deok-cheol, Minister of Healt
- Policy
- Results of HIRA’s preemptive response to COVID-19
- by Lee, Hye-Kyung Apr 27, 2021 06:05am
- In the ‘2020 sustainable management report’ published by the Health Insurance Review and Assessment Service (HIRA), the institution cited its preemptive COVID-19 response as one of its achievements last year. HIRA, which had organized a COVID-19 Countermeasure Promotion Committee in response to the COVID-19 pandemic, evaluated its perf
- Policy
- The industry is paying attention to the review of generics
- by Lee, Jeong-Hwan Apr 27, 2021 06:04am
- Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's Health and Welfare committee (Legislative Subcommittee) to be held next week. The two bills initiated by Democratic Party of Korea Rep. Seo You
- Policy
- Generics for Pradaxa · Xarelto are scheduled to be released
- by Lee, Tak-Sun Apr 26, 2021 05:52am
- Due to the failure of the patent challenge, sales of the domestic NOAC (oral anticoagulant drug), generic for Eliquis (Apixaban) product, will be suspended for the time being. But within this year Pradaxa (Dabigatran Etexilate Mesylate) and Xarelto (Rivaroxaban), other types of NOAC generics are expected to be released, so domestic pharmaceu
- Policy
- The authorities is monitoring Sputnik V's overseas data
- by Kim, Jung-Ju Apr 26, 2021 05:51am
- Regarding the information that Cheongwadae and the licensing authorities are trying to introduce Russia's COVID-19 vaccine, Sputnik V, the Central Disease Control Headquarters said, "It is still in the stage of collecting and monitoring foreign data," and that no application for permission has been received from the company. The Central Di
