- 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
- Company
- Will SK hand over Xarelto generic exclusivity rights to GC?
- by Kim, Jin-Gu Apr 29, 2021 06:09am
- SK Chemicals may decide to hand over the hard-won generic exclusivity for its generic version of ‘Xarelto (rivaroxaban) 2.5mg’ to GC Pharma. If GC Pharma takes over SK Chemicals’ generic exclusivity, the company will be able to enjoy market exclusivity for the low-dose Xarelto generic with Hanmi Pharmaceutical from this October to
- 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
- Company
- Epidiolex can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Apr 28, 2021 06:05am
- Epidiolex can be prescribed at general hospitals in Korea According to related industries, Epidiolex (Cannabidiol, CBD Oil), a hemp-based drug for the treatment of patients with rare and intractable diseases among children with epilepsy, has passed the drug commitee (DC) of Seoul National University Hospital. Epidiolex has been reimburs
- Company
- Viatris Korea-Jeil Pharm to co-promote Lipitor Plus from May
- by Eo, Yun-Ho Apr 28, 2021 06:05am
- On the 27th, Viatris Korea and Jeil Pharmaceutical announced that they will launch and co-promote the dyslipidemia treatment ‘Lipitor Plus (atorvastatin and ezetimibe)' from May 1st. Jeil Pharmaceutical had received approval for Lipitor Plus from the Ministry of Food and Safety on February 18th, in 3 dosages - 10/10mg, 10/20mg, 10/40mg
- Company
- Celltrion acquires Nesina and Actos from Takeda
- by Kim, Jin-Gu Apr 28, 2021 06:05am
- According to the pharmaceutical industry on the 26th, some of the 18 items that Celltrion acquired from Takeda last year are still being sold under the name of Takeda. This is because the license right in Korea has not yet been completely transferred to Celltrion. Celltrion acquired the rights of 18 items for chronic disease treatment a
- Company
- Generics for Eliquis have Rx amount of ₩12.7 billion
- by Kim, Jin-Gu Apr 28, 2021 06:05am
- It was found that Eliquis (Apixaban)'s cumulative prescription amount for generics, which faced a crisis of compensation for damages due to the Supreme Court decision made earlier this month, reached &8361;12.7 billion. With the sale of generics stopped at once after the Supreme Court ruling, generic companies have to pay a significant porti
