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- 2026-04-14 23:24:30
- Company
- Dong-A ST’s Nesp biosimilar export exceeds ₩10 bil.
- by An, Kyung-Jin May 03, 2021 05:53am
- Pic of the Darbepoetin-α product being sold in Japan The cumulative export sales of Dong-A ST’s biosimilar anemia treatment have exceeded 10 billion won. After entering the Japanese market through a partner company at the end of 2019, the sales of Dong-A ST's biosimilar have shown steady growth based on the increasing product recognition and favorable policies set on biosimilars by the Japanese government. According to Dong-A ST on the 1st, its overseas sales of ‘Darbepoetin-alfa’ during the first quarter of this year was 2.9 billion won, a 326.6% increase from the same period of the previous year. ‘Darbepoetin-alfa’ is a biosimilar of the second generation anemia treatment ‘Nesp (darbepoetin-α)’ that was co-developed by Amgen and Kyowa Kirin. Its mechanism of action allows erythropoietin (EPO) to stimulate erythroblasts and accelerate red blood cell production and is used to treat patients with anemia from chronic renal failure or from chemotherapy. The overseas sales of ‘Darbepoetin-alfa’ are solely accrued from its Japan exports. After conducting the Phase I clinical trial on’ Darbepoetin-α,’ Dong-A ST signed a licensing-out agreement on the development and sale of its drug to Sanwa Kagaku Kenkyusho (SKK). Based on a Phase III trial conducted in Japan that compared the efficacy and safety of ‘Darbepoetin-α’ to the original ‘Nesp,’ SKK received marketing approval from Japan's Ministry of Health, Labor and Welfare in September 2019 and released the drug from November of the same year. Dong-A ST exports the finished products that were produced by DM Bio, a biosimilar company under Dong-A Socio Group, to SKK, after which SKK is solely responsible for its local sales. After recording 0.1 billion won in sales in the first year of its release, ‘Darbepoetin-alfa' started making real profit from last year. After exceeding 2 billion won in sales in the second quarter of last year, it has been selling around 3 billion won’s worth every quarter. The cumulative export sales of ‘Darbepoetin-alfa’ since its launch in 2019 to the first quarter of this year amounts to 11.8 billion won. Chong Kun Dang has also launched a Nesp biosimilar in the same market. The company had received marketing approval for its Nesp biosimilar ‘Nesbell’ at a similar period with Dong-A ST and released its product in December of the same year. The Japanese subsidiary of U.S. global pharmaceutical company, Mylan N.V., is in charge of its sales in Japan, however, Chong Kun Dang has not disclosed the individual sales performance of ‘Nesbell’ in Japan. An official from Dong-A ST said, “It has been three years since we released our ‘Darbepoetin-alfa' in Japan, and brand recognition of our product has been increasing. The advantage that our product is cheaper than the original drug, and the subsidies provided by the Japanese government to hospitals that use biosimilars, have also added to our continued positive increase in sales.”
- Policy
- The number of COVID-19 vaccinations exceeded 3 million
- by Kim, Jung-Ju May 03, 2021 05:53am
- The cumulative value of the first vaccination patients who received COVID-19 vaccine exceeded 3 million. The quarantine authorities achieved the cumulative amount of vaccinations one day earlier than the initial target set by the quarantine authorities, and the authorities predict that 12 million vaccinations in the first half can be carried out without any problems. COVID-19 Vaccination Response Promotion Team (KCDA Commissioner Jeong Eun-kyeong) said that as of 3:30 pm today (29th), 3,012,654 people (provisional count) who received the vaccine (based on the first vaccination), It has been revealed that it has exceeded 3 million. In response to this, the promotion team explained, "reinforced vaccination capabilities, such as opening additional vaccination centers and early operation of consigned medical institutions, and expanding vaccination targets according to the vaccination sequence, and trusting experts and the government to actively participate in vaccination. Thanks to the medical staff who safely administered the vaccination." The promotion team said that the originally established vaccination plan was proceeding smoothly, about 80% of vaccinations in nursing hospitals and facilities, where there were many seriously ill patients and fatalities, were also achieved, and that the vaccination of essential social personnel is also accelerating. The promotion team explained that it plans to strengthen the surveillance of adverse reactions with the medical community and continue compensation for damage so that the public can receive vaccinations more safely. The promotion team said, "We will inoculate 12 million people (based on the first vaccination) for the elderly, high-risk groups, quarantine and medical personnel, etc. by the end of June, and use it as a starting point for recovery to daily life." The promotion team requested that the people actively participate in vaccination on a healthy day, when the vaccination order came.
- Company
- Yungjin won patent dispute on Abilify after 6 years
- by Kim, Jin-Gu May 03, 2021 05:53am
- Yungjin won the patent dispute between Otsuka and Yungjin over Abilify (Aripiprazole), a treatment for schizophrenia and bipolar disorder, in six years. This added Abilify's indication for bipolar disorder. Yungjin, which won the dispute, relieved the burden of compensation for damages caused by patent infringement. ◆Generic release as an indication for schizophrenia after product patent expiration On the 29th, the Supreme Court reaffirmed the court's decision in the Abilify patent invalidation lawsuit between Otsuka and Yungjin and dismissed the appeal. It has been six years since the conflict began. In 2014, when Abilify's product patents expired, domestic companies entered the generic market one after another. There are five indications of Abilify: schizophrenia, bipolar disorder, major depressive disorder, autism disorder, and Tourette syndrome. Among them, only the indication for schizophrenia was applied due to the expiration of the product patent. Indications for bipolar disorder and major depressive disorder have been expanded as Otsuka's use patent (expired in 2022) was listed. Considering that Abilify is used for both schizophrenia and bipolar disorder, it was beneficial to launch it in both indications. In March 2015, Yungjin filed a trial claiming that the use patent for bipolar disorder was invalidated. However, the Intellectual Property Trial and Appeal Board took the side of the original company Otsuka in October 2016. Otsuka pushed generic companies in all directions by requesting a trial to verify the scope of their rights and sending out certification of contents. Eventually, generic companies sold only as schizophrenia, excluding bipolar disorder, as an indication. ◆Yungjin, including indications for bipolar disorder However, Yungjin was an exception. Yungjin continued fighting against the defeat of the first trial. It filed a lawsuit with the Patent Court of Korea to cancel the trial decision. The Patent Court of Korea overturned the first trial decision. In July 2017, on the side of Yungjin, he ruled that the patent for use with bipolar disorder was invalid. Otsuka objected. Through an appeal, the case was taken to the Supreme Court. A fierce legal dispute ensued in the Supreme Court. The conclusion came out after 3 years. As with the second trial, a ruling was handed over to Yungjin's side. The ruling included Abilify's indications for bipolar disorder, allowing Yungjin as well as other generics to add indications for bipolar disorder to schizophrenia. It can be added immediately after the trial for reversal of revocation in the Patent Court is concluded with a final judgment. Yungjin escaped the crisis of large-scale counterindemnity. If the Supreme Court ruled in favor of Otsuka, it was because Yungjin had to hand over a significant portion of the sales revenue of generics over the past five years to Otsuka. An official from Yungjin said, "Yungjin had a dispute alone. It was defeated in the first trial, but under the judgment that the logic of invalidity was certain, the second trial was enforced and finally won." He predicted that "Otsuka is also in the process of action against infringement of patent, apart from this lawsuit. It is currently in the process of winning the first trial and in the patent court. In line with this Supreme Court decision, the action against infringement of patent will also be finalized." Patent Attorney Park Jong-hyuk, who represented Yungjin, said, "Unlike composition patents and formulation patents, it is not easy to obtain an invalidation judgment. The Supreme Court recently sided with the patentee, but it means that a ruling to invalidate the use patent was made.” He explained "Bipolar disorder is a recurrent disease of two opposing conditions, mania and depression. It is the judgment of the Supreme Court that if there are no experimental data that clearly show the therapeutic effect of both diseases, it is invalid as a description." According to UBIST, a pharmaceutical market research institute, the amount of Aripiprazole's outpatient prescription last year was ₩25.3 billion. Among them, the generic prescription amount is ₩1.3 billion. However, considering that the prescription of Aripiprazole is 40% to 50% for schizophrenia, 30% to 40% for bipolar disorder, and 20% to 30% for the rest of major depressive disorders, the addition of indications for bipolar disorder will increase the prescription performance of generic companies. It is expected to work positively.
- InterView
- "Embrace precision medicine and tumor-agnostic therapy"
- by Eo, Yun-Ho Apr 30, 2021 06:12am
- 박경화 교수 “It’s our turn to adjust to tumor-agnostic therapies." HER2, ALK, EGFR, ROS1. These are keywords that frequently catch our eye in news about anticancer drugs. Times have changed. Effective treatment for patients these days depends on the genetic mutation of each patient. With treatments that target personalized genes continue being introduced, the development of precision medicine has heralded the shift in the field of anticancer treatment from ‘disease-based' to ‘gene-based' treatment. For example, Roche’s Neurotrophic tyrosine receptor kinase (NTRK) ‘Rozlytrek (entrectinib)’ has already been approved as a tumor-agnostic anticancer drug in Korea. Also, MSD’s PD-1 inhibitor immunotherapy ‘Keytruda (pembrolizumab)’ has been adding various indications in patients with microsatellite instability-high (MSI-H) tumors. Dailypharm met with Dr. Kyong-Hwa Park, Professor of Oncology and Hematology at Korea University Anam Hospital, an authority in the field of precision medicine in Korea who also runs the K-Master program, to hear about the currently accessible yet unfamiliar world of personalized treatment, and the paradigm shifts that have occurred in anticancer treatment with the introduction of precision medicine. -Precision medicine has become an inevitable trend. Please tell us about the K-Master project, its progress, and outcome.. Initially, our 5-year goal was to file genome sequencing of 10,000 patients with solid cancer and to launch 20 clinical trials. Based on the data, we wanted to provide new treatment opportunities to patients and create grounds to expand treatment indications. We are in our fifth year, and our project will close on December 31st this year. Since we already have registered and secured genome sequencing data on 9,000 cases, I think we will be able to easily reach our goal. We are also currently conducting 20 trials. Due to the characteristics of precision medicine, the 20 clinical trials could not be initiated all at once, so we needed to sequentially proceed on with our research. In other research areas, we could have started all the trials in the first year. However, precision medicine differs from other areas because of its unmet needs, as well as its unique timeline of drug development that depends on the discovery of new genes. -What is the K-Master program’s strength in conducting clinical trials? Our role model was the NCI (National Cancer Institute)-Match trial. Based on the trial and its limitations, we complemented and improved our project from its initial stages. When 50 institutions under the Korean Cancer Study Group send sample tissues, Central conducts NGS sequencing; however, if the sample tissues do not pass QC, the process of recollecting the tissues take long, and in some cases result in the non-registration of those patients. For our project, we increased the registration success rate by profiling the samples via a liquid biopsy platform to allow the use of blood samples for genome sequencing of patients whose tissues are unavailable or do not pass QC. - Two drugs, including Rozlytrek, were approved in Korea. These tumor-agnostics targeted therapies seem like typical examples of how ‘personalized medicine’ and ‘precision medicine’ are entering our society. What changes do you expect to see in Korea with the introduction of such medicines? The method of how we classify cancer has changed with the introduction of precision medicine. If cancer was classified by location in the past, like lung cancer, colorectal cancer, breast cancer, etc., now it is divided by pathway. So we can now classify cancer as those with HER2 overexpression, HER2 mutation, NTRK mutation, etc. Patients with such cancers are very rare, but doctors now know what to prescribe when such cases arise because we have research and findings on such cases. We can therefore use various methods to find the NTRK-mutations such as DNA sequencing, RNA sequencing, at the protein level or by FISH, etc. As DNA NGS has low sensitivity, we would be lucky to find the mutation at that level. However, for suspected patients, doctors can also order FISH or IHC tests. -Reimbursement remains an obvious issue. Reimbursing tumor-agnostic treatments must be a burden from the government’s perspective. When treatment for rare cancer types that occur in specific genes are granted evidence-based approval in the market, reimbursement should also be considered. I believe the higher-priced drugs can be reimbursed as rare cancer patients have a shorter life expectancy. Less than 1% of all solid cancer patients in Korea fall into the rare cancer patient category that can benefit from such advanced treatments. Considering our diagnostic efficiency, this amounts up to less than 200 patients. We are talking about providing treatment benefits to these very rare patients. If reimbursement is possible, it should be provided. Rare cancer patients typically do not respond to standard treatments. For example, breast cancer patients that do not respond to standard of care therapies show NTRK mutations. As these patients benefit a very short time from standard treatment, reimbursement of NTRK inhibitors for this population should also be possible. Overall, we need to devise a separate reimbursement track for precision medicine. With the introduction of Keytruda in MSI-H and Rozlytrek, there is a pressing need to prepare a separate reimbursement review standard for tumor-agnostic treatments that suits our current situation. If precision medicine is available according to a patients' NGS screening result, they should not be left to feel the immense deprivation of not being able to use the drug due to accessibility issues.
- Company
- SGLT-2 inhibitor combos drive sales in diabetes market
- by Kim, Jin-Gu Apr 30, 2021 06:10am
- The domestic sales of sodium-glucose transport protein-2 (SGLT-2) inhibitors in the diabetes treatment market have repeatedly marked rapid growth. The outpatient prescription sales of SGLT-2 inhibitors in Q1 this year increased by 14% from the previous year, continuing its double-digit growth. The growth is driven by combination therapies. Prescriptions of the two combo therapies ‘Xigduo’ and ‘Jardiance Duo’ have increased by 2.3 times over the past two years. ◆2.3 times increase in prescription of combo drugs… market share also jumps from 27%→39% According to pharmaceutical market research firm UBIST on the 29th, the SGLT-2 inhibitor class of antidiabetic treatments has recorded a total of 32.1 billion won in outpatient prescription sales in Q1 this year. This is a 14% increase from Q1 of the previous year. The SGLT-2 inhibitor market has been increasing quarter by quarter since AstraZeneca’s ‘Forxiga (dapagliflozin) was first introduced to the market in June 2014. Following AstraZeneca, Astellas Pharma’s ‘Suglat (ipragliflozin),’ Boehringer Ingelheim’s ‘Jardiance (empagliflozin),’ MSD’s ‘Steglatro (ertugliflozin),’ also entered the market. Prescription sales of SGLT-2 inhibitors for the last 2 years have been 20.9 billion won in Q1, 23 billion won in Q2, 24.2 billion won in Q3, and 26.1 billion won in Q4 of 2019, and 28.1 billion won in Q1, 29.2 billion won in Q2, 32 billion won in Q3 and 32.1 billion won in Q4 of 2020. The recent market growth has been driven by combination therapies. The SGLT-2 inhibitor combos, AstraZeneca’s ‘Xigduo’ and Boehringer Ingelheim’s ‘Jardiance,’ are in fierce competition. Both drugs are combination therapies that have added metformin to each company’s SGLT-2 inhibitor. At first, total prescription sales of the two products amounted to a mere 5.6 billion won in Q1 2019, with their combined market share being 27%. However, sales have increased over twofold over the next 2 years to reach 12.7 billion won, and their market share also expanded to reach 39%. By each product, Xigduo sold 7.7 billion won, and Jardiance Duo sold 5 billion won in Q1 of this year. The growth surge is more notable in Jardiance Duo, with a 58% increase from Q1 of the previous year. Xigduo also saw a 19% growth during the same period. ◆Forxiga·Jardiance both record ₩9.1 billion… market expected to increase with indication expansion Among monotherapies, Forxiga and Jardiance have recorded 9.1 billion won each. This is an 8% increase for Jardiance and a 4% increase for Forxiga compared to the previous year. Despite the market’s rapid growth, Suglat and Steglatro, however, has shown reduced performance. The prescriptions sales of Suglat and Steglatro recorded only 0.8 billion won and 0.5 billion won in Q1 this year. This was a 4% and 19% respective decrease compared to the Q1 of last year. Industry officials expect the growth of Forxiga and Jardiance to continue for a while. The biggest reason being their expanded indication. In December last year, Forxiiga succeeded in adding a chronic heart failure indication in Korea. As a result, the drug may be used for heart failure, with or without diabetes. Jardiance also has submitted an application for the same indication and is awaiting approval. One variable that might hinder this growth is the release of follow-on drugs by domestic pharmaceutical companies. Currently, Dong-A ST is the only company to have successfully avoided Forxiga's substance patent (to expire in April 2023). The second and third trial remains, however, the company has met the requirements to release a follow-on drug. If wishing to do so, Dong-A ST could release a follow-on drug within this year. Also, Daewoong Pharmaceutical has been speeding up the development of its new drug 'Enavogliflozin.' With Phase III clinical trials currently underway, Daewoong aims to roll out its drug in 2023.
- Policy
- There is no problem with AZ vaccine safety
- by Kim, Jung-Ju Apr 30, 2021 06:09am
- The government announced that it is concerned about the avoidance of the AstraZenega (AZ) COVID-19 vaccine due to the thrombosis side effect issue. It is said that there are no safety issues with side effects and solutions that appear around the world. Son Young-rae, Team Leader of Countermeasure Headquarters COVID-19 Social Strategy, answered this way through Q&A for regular briefings in the morning of today (28th). He said, "Recently, the amount of COVID-19 vaccine secured by purchasing additional Pfizer vaccines has increased to a total of 99 million this year. As the supply of vaccines from other companies is increasing, we are concerned about the phenomenon of avoiding AZ vaccination." He said, "In the case of the UK, half of the vaccination targets are AZ products. tens of millions of people are inoculated, so our government continues to monitor it." He said, "There is no problem with safety and rare thrombosis, which appears as a side effect, is also extremely rare, and because it is possible to treat it, the practical benefit of vaccination is high, so the Korean government also recommends vaccination." “Experts are also recommending AZ vaccination in common, and the Central Disaster Management Headquarters and the Central Disease Control Headquarters (employees) are also vaccinating AZ products. I hope that the people do not worry more than necessary, and that the AZ product candidates receive the vaccine as much as possible." The authorities forecast the completion of domestic vaccine development in the first half of next year. Five pharmaceutical companies have entered clinical trials through vaccine development, and it is expected to enter phase 3 as soon as possible in the second half of this year. He said, "It is the principle that domestic vaccines are supported until they are successful, and the government is actively supporting them with the aim of developing them in the first half of next year. It is difficult to recruit subjects due to the small number of domestic patients, but we will also review and apply for comparative clinical trials."
- Product
- The price of Rotarix has also increased
- by Moon, sung-ho Apr 30, 2021 06:09am
- As prices have increased for cervical cancer vaccines and rotavirus vaccines that prevent neonatal enteritis, the burden on hospitals and clinics is increasing. Some medical organizations are raising the issue of unilateral price hikes for global pharmaceutical companies, but there is currently no clear solution. The medical staff who have to deal with the complaints of the patients are worried a lot. According to the pharmaceutical industry on the 15th, from this month, MSD Korea increased its supply price by 15% for the cervical cancer prevention vaccine Gardasil 9 and 17% for the rotavirus vaccine Rotarix. The information has been guided to hospitals and clinics by HK inno.N, which is in charge of MSD sales since the beginning of this year. Rotarix produced by GSK is also expected to increase by 12% from May. Kwang Dong, which is in charge of Rotarix, recently guided this to hospitals and clinics. According to the HIRA, the currently nonreimbursement price of Gardasil 9 for hospitals and clinics is distributed between ₩107,928 and ₩202,524. Gardasil 9 is a vaccine that requires a total of 3 doses to complete the vaccination, so it costs up to ₩600,000. In the case of RotaTeq, the nonreimubursement price ranges from ₩48,100 to ₩130,000, which averages ₩92,473. Rotarix produced by GSK is distributed at ₩63,600 to ₩150,000, which is slightly more expensive than MSD's RotaTeq. The average price is ₩125,751. Gardasil 9 is up 15%, RotaTeq is up 17%, and Rotarix is up 12%. MSD's opposition to the Gardasil 9's impression eventually came to a medical organization to seek understanding, but it is an opinion that it is difficult for medical organizations to understand pharmaceutical companies. "We had a time to share the contents of the vaccine supply price increase with MSD," said Lee Ki-cheol, vice president of the Korean Association of Obstericians & Gynecologists. "There are many aspects that are difficult to understand from the standpoint of the medical community.” "The supply price is quite high, with a 15% increase. This is unusual and very burdensome. We are going to send a letter to protest against it," he emphasized. "Pharmaceutical companies say that the domestic supply price is not higher than the foreign supply price," said Ma Sang-hyuk, vice-chairman of The Korean Vaccine Society (Daegu Fatima Hospital, Pediatrics and Youth Division). He said, "It is difficult to adjust the price because even if the supply price of vaccines is raised, It depends on the pharmaceutical company in the case of non-reimbursement items. It is difficult to get involved legally, so it is only the doctor's role to get patient complaints." "This is because the related market operates exclusively," said Lee Ki-cheol, vice president of insurance at the KAOG. "As the related supply system has been improved, policy improvements are needed to prevent this from happening again," he argued. MSD believes that a price increase is inevitable because the price hikes of major non-reimbursement vaccines, including Gardasil 9, require production-specific complexity, long production periods, and quality control processes. In addition, MDS explained that it is working to reduce discomfort to medical staff and patients.
- Company
- Otsuka recently signed a co-promotion contract with Boryung
- by Apr 30, 2021 06:09am
- Otsuka Otsuka will co-promote with Boryung to maintain IMD Mucosta SR in the Rebamipide market. The gastrointestinal drug Rebamipide market, worth ₩100 billion, has recently been fiercely competitive. In December of last year, Yuhan (Recomid SR), GC Pharma (Mucotect SR), Daewoong Pharmaceutical (Mucotra SR), and Daewon Pharmaceutical (Bidreba SR) were approved for IMD of Rebamipide. While Rebamipide is taken three times a day, these IMDs are taken twice a day. A competitive drug has been released in the existing market where generics have been the only so far. The launch of IMDs affected Mucosta's sales, which account for about 10% of Otsuka's total sales. Mucosta recorded ₩17.3 billion in outpatient prescriptions based on UBIST last year. It was down 5.5% from the previous year. Last year's prescription for Bamedin by Samjin was ₩4.6 billion. In order to maintain the No. 1 position in market share, Otsuka was also approved for an IMD Mucosta SR in January after 30 years. Four domestic companies, including Yuhan, are the same through joint development, but Otsuka, which was developed independently, shows a slight difference from the products of the four companies. Otsuka recently signed a co-promotion contract with Yuhan. The original Mucosta could be replaced with a company's product rather than IMD by other companies. The two companies' co-promotion contracts were announced later. In particular, Boryung is expected to play an active part in the highly competitive clinics. Boryung is also in charge of selling Otsuka's antithrombotic drug Pletaal. Domestic pharmaceutical companies were not interested in Rebamipide. This is because the growth trend was insignificant even after 30 years of launch. However, the situation has changed starting with the Ranitidine Incident in September 2019. After Ranitidine was expelled, it affected the growth of Rebamipide. The Rebamipide market, which was only growing at an annual average of around 4%, increased 14.8% year-on-year to ₩110.6 billion in 2020. Existing Rebamipide trend by item
- 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 after vaccination with AstraZeneca COVID-19 vaccine. On the 8th, the MFDS issued a safety letter regarding a specific thrombosis with thrombocytopenia of the AstraZeneca COVID-19 vaccine. It is explained that additional necessary measures have been reviewed. Through the Central Pharmaceutical Affairs Review Committee meeting on the 20th, the MFDS received advice on the safety and action of the AstraZeneca COVID-19 vaccine against the occurrence of blood clots. As a result, vaccination did not increase the overall risk of thrombosis, and the unique thrombosis with thrombocytopenia, which has not yet occurred in Korea, is very rare outside the country. As in the evaluation, we received an opinion that it was judged that there was a possibility of a causal relationship with the vaccine. Accordingly, the Central Pharmaceutical Affairs Review Committee concluded that it is reasonable to change the information on unique thrombosis with thrombocytopenia in addition to the precautions for use. As a precaution for use, ▲people who have experienced major venous or arterial thrombosis with thrombocytopenia after vaccination of COVID-19 should not receive this vaccine.▲ It should be carefully administered to patients with a history of thrombosis in uncommon areas such as cerebral sinus thrombosis and visceral venous thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome, and risk factors for thromboembolism and thrombocytopenia. ▲ After vaccination, serious cases of thrombosis with thrombocytopenia were observed very rarely, and ▲ people pay attention to the signs and symptoms of thromboembolism, thrombocytopenia and coagulation Accordingly, health care professionals should pay attention to the signs and symptoms of thrombosis and thrombocytopenia after vaccination so that patients can be treated promptly; and, after vaccination, severe or persistent headaches, blurred vision, confusion, and If symptoms such as seizures, shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain, skin bruising or spotting bleeding other than the injection site appear, seek medical attention immediately. An official from the MFDS said, "We will continue to monitor abnormal cases after vaccination against COVID-19 in the future. In addition, we will promptly inform safety and whether or not measures are necessary through expert advice."
- 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 Nitadin, Nex by Binex, and Ari's Artidine, which are used as GI drugs . All are products of Nizatidine. Nizatidine was temporarily banned from selling the item because NDMA was detected in 13 products in November 2019. The items to be recalled at this time are different from those found at the time. The MFDS explained that as NDMA is detected in the company's own product stability test, it is proceeding with recovery as a precautionary measure. All four items are consigned by Binex. Binex is consigning production of a total of 9 items, including its own. Therefore, NDMA was detected again in the product. It is known that this product recovery was triggered by an accelerated test conducted by the pharmaceutical company itself. The accelerated test is a test to find out the stability of a drug under conditions beyond the standard of storage for distribution. Nizatidine can be stored at room temperature between 1°C and 30°C, but NDMA was detected as a result of testing at higher temperatures and humidity. Dr. Reddy's Laboratories reported that NDMA was detected in the accelerated Nizatidine test and reported to the drug product company it trades. It is observed as a follow-up action by a drug product company starting from Dr. Reddy's Laboratories. The problem is Dr. Pharmaceutical companies that use Reddy's Laboratories' ingredients are not the only four pharmaceutical companies that are collecting items this time. All 13 items that were temporarily banned from sale and recalled in November 2019, when the MFDS discovered the NDMA problem in Nizatidine, all used raw materials from Solara Active Pharma Sciences. Dr. Reddy's Laboratories and Nizatidine products using domestic ingredients were able to sustain sales. Dr. It is known that among the items using Reddy's Laboratories raw materials, there are also items with relatively high sales. The pharmaceutical industry analyzes that Dr. Reddy's Laboratories raw materials can also cause problems, affecting other finished products using the same raw materials. An official in the pharmaceutical industry said, "There are a lot of domestic distribution items that use the ingredients of Dr. Reddy's Laboratories. However, it remains to be seen how many items NDMA is detected in the accelerated tests of finished products of these companies." The MFDS said, "The items in which NDMA was detected in this accelerated test are not commercially distributed items. As a precautionary measure, it recommended the drug company to recall." The MFDS added, "This issue is the company's action in accordance with the instructions for evaluating the likelihood of occurrence such as NDMA for all drugs. However, he added that there is a possibility that there may be more items to be recalled according to the results of the company's own test. "
