- Policy
- 241 items of the impurity detected Losartan were recovered
- by Lee, Tak-Sun Dec 14, 2021 05:56am
- Azido impurities are detected in Losartan, HTN treatment , and all 241 items are recovered, and only some manufacturing numbers of 54 items are recovered. However, 11 items are sold as they are because impurities are not detected excessively. The MFDS explained that the risk of harm to the human body is very low, but in the case of pati
- Policy
- Phase III for Amivantamab-Lazertinib was approved
- by Lee, Tak-Sun Dec 13, 2021 05:57am
- Lazertinib was exported to Janssen in 2018 worth 1.4 trillion won. Janssen is attempting to overcome existing treatments through the combination of its developed non-small cell lung cancer treatment "Amivantamab (Rybrevant)" and Lazertinib. The MFDS approved a phase 3 clinical trial plan for "JNJ-61186372" applied by Janssen Korea on the 1
- Policy
- MFDS is considering changing the permission of Remdesivir
- by Lee, Tak-Sun Dec 13, 2021 05:56am
- Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved. In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results. At that time, the MFDS quickly approved the final results of clinical trials, som
- Policy
- Janssen Korea voluntarily withdrew Tylenol 500mg
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- It is known that the item license for Janssen Korea's antipyretic analgesic "Tylenol 500mg" will be withdrawn soon. This was expected to some extent because the Hyangnam plant will be shut down at the end of this year. Janssen has already been approved for imported items with the same ingredients and the same dosage. According to the MFDS on
- Policy
- The method of writing for HBP combination is improved
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- The method of writing permission for HBP and dyslipidemia combinations is improved more efficiently. Previously, information on individual ingredients was simply listed, but in the future, it will be prepared based on a comprehensive evaluation of combinations. According to the pharmaceutical industry on the 6th, the MFDS prepared a plan
- Policy
- The ruling party shouted to review the Judiciary Committee
- by Lee, Jeong-Hwan Dec 9, 2021 05:58am
- The ruling party members of the Health and Welfare Committee issued a statement and strongly protested when the revision to the National Health Insurance Act, which included strict regulations on doctor licenses, and the bill to return and refund drug prices, were put on hold at the stage of the Legislation and Judiciary Committee. Members
- Policy
- 6 cases of Ultomiris & 1 case of Spinraza were pre-approved
- by Lee, Hye-Kyung Dec 9, 2021 05:58am
- Benefits for pre-approval of six new PNH patients for Ultomiris administration were approved and four cases were rejected. There were no applications for new salary administration for Soliris, but two applications for pre-approval for new aHUS patients were not accepted. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA
- Policy
- Patients fume over non-deliberation of Kymriah·Keytruda
- by Lee, Jeong-Hwan Dec 9, 2021 05:58am
- Patients have set out to demand PBAC's prompt deliberation of the new reimbursement listing for Novartis Korea’s cancer immunotherapy Kymriah in acute lymphoblastic leukemia and diffuse large B-cell lymphoma and reimbursement expansion for MSD Korea’s non-small cell lung cancer treatment Keytruda to first-line in NSCLC. The patients exp
- Policy
- Impurity detected Cozaar is excluded from recovery
- by Lee, Tak-Sun Dec 8, 2021 06:01am
- In the case of a single drug in Losartan formulation where impurities were detected, it is interpreted that only the original drug was excluded from recovery, exposing the risk of domestic generics again. It is analyzed that the reason why the original drug was excluded from the collection list is because the raw material process is differ
- Policy
- No recall crisis expected to arise from losartan impurities
- by Lee, Tak-Sun Dec 8, 2021 06:00am
- Although 295 antihypertensive treatments that were found with impurities were ordered recalled, due to the low risk and specificity of the targeted items, no disruption is expected from the exchange, re-prescriptions, or re-dispensing of such drugs. The Ministry of Food and Drug Safety announced on the 7th that 295 losartan items that wer
