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- 2026-04-17 06:15:02
- Company
- SK nabs approval for cilostazol-ginko combination SR drug
- by Lee, Seok-Jun Mar 29, 2020 11:19pm
- On Mar. 25, SK Chemicals has announced the Korean health authority has approved sustained release tablet version of antiplatelet drug Renexin. Renexin is a combination drug consisting of antiplatelet agent cilostazol (200 mg) and ginko biloba extract (160 mg). The combination drug, with cilostazol and ginko biloba extract inhibiting platelet aggregation and blood clot formation, has been confirmed to be effective on improving chronic total occlusions in peripheral arteries-induced ischemic events and preventing recurrent stroke. The Korean-made drug is the world’s first drug to combine the two agents. Moreover, Renexin sustained-release (SR) tablet has significantly reduced the number of adverse events like headache in cilostazol. A Phase III clinical trial conducted in 18 Korean clinical institutes including Severance Hospital has found Renexin SR tablet reduced the prevalence of adverse events by 43 percent than the existing tablet. The SR tablet has also enhanced patients’ drug adherence and convenience with once-daily administration.
- Company
- Lipitor and Vytorin to be priced lower than generic?
- by Eo, Yun-Ho Mar 29, 2020 11:18pm
- An odd phenomenon of the original’s pricing dipping down to 85 percent of the lowest generic pricing may actually happen in Korea. The stepped drug pricing system coming in effect from July prices same-substance drugs under differentiated pricing depending on drugs meeting two qualifying standards. But from 21st same-substance drug, the pricing is fixed at 85 percent of the lower price between the lowest price of the drugs or 38.69 percent of the original’s price. However, a controversy sparked when the Ministry of Health and Welfare (MOHW) explained the stepped drug pricing system would be applied on ownership-transferred drugs. Pharmaceutical companies splitting recently like Pfizer and MSD are currently in process of transferring multiple original products to their spin-offs. And these companies may get impacted critically by the government’s interpretation. ◆"Transferred original? To the back of the line!” The controversy over the reduced original pricing started from the ‘Pharmaceutical Decision and Adjustment Standards’ revised in last February. The Section Ma (마) of the revised drug pricing notice stipulates a drug applying for pricing decision, listed previously but removed, would be priced at its latest maximum price, if it is either a transferred drug by inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 1 of Article 89, or a transferred drug by importer’s inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 2 of Article 42. In other words, the manufacturer (usually a Korean company) or the importer (multinational company) transferring a drug with a business license would not be subject to pricing reduction. Nevertheless, the Section Ba (바) of the notice stipulates a drug applying for pricing decision, listed previously but removed, would be priced at a lower price between its latest maximum price or newly calculated price, if it is a transferred drug by the manufacturer’s business transfer as stated by the Pharmaceutical Affairs Act Paragraph 2 of Article 89. This could mean the drug reapplying for pricing could face pricing reduction depending on the number of listed generics and standard qualification stated by the drug pricing notice. For example, the first-in-class pharmaceutical reimbursement on Lipitor (atorvastatin) is removed in the process of Upjohn splitting off from Pfizer and taking over the drug. But Lipitor’s price would fall at 85 percent of same-substance drugs as it would be treated as a generic when reapplying for the listing with more than 20 generic already listed. MOHW official commented, “The Pharmaceutical Decision and Adjustment Standards do not distinguish original or generic, but it manages listing of ‘drugs.’ We see no reason for us to exempt first-in-class drug (usually an original) from the newly revised pricing calculation standards.” ◆"Inconsistent with the policy’s objective, exempt the original from pricing reduction” Basically, the industry is a turmoil. Some of them are considering on taking legal actions to protect their originals getting a price lower than generics. Nevertheless, there is a chance for pharmaceutical companies to protect the original’s pricing even with imminent business and product transfer issues. MOHW has decided to apply the existing standards on products applying for listed pricing by May 2020, unless the products have special condition or need to submit additional data. Therefore, if Upjohn and Organon splitting off from Pfizer and MSD, respectively, were to process the transfer fast enough, they would be able to avoid the pricing reduction. Upjohn would take over Lipitor, Norvasc and Celebrex, whereas Organon is planning to take over Vytorin, Singulair and Zetia. But the window is opened to those two companies only. Multinational companies splitting off-patent drug specializing division in the future would take a heavy blow. In fact, many of global companies are either planning to or considering on a spin-off. Increasing number of Korean companies is also shooting for transferring originals. Because of the situation, Pfizer and MSD may request for rapid approval from their respective headquarters to finalize the transfer earlier. The pharmaceutical industry is infuriated at the Korean government. Considering the generic pricing system revision started from the safety issue of valsartan, the companies cannot accept the Pharmaceutical Decision and Adjustment Standards working against the original and reducing its price. Korean Research-based Pharmaceutical Industry Association (KRPIA) insider noted, “Although the generic pricing calculation has been modified, the contradicting factor in the existing regulation has not been touched up and created a loophole. The association has delivered the industry’s opinion, but we did not get the answer we wanted. The government would have to promptly set down correct interpretation of the regulation coinciding with the original objective of the revision and prevent any confusion in the market.” Regarding the issue, Attorney Lee Hyeong Gun and Song Hyun Ah at Lee & Ko commented, “The new generic pricing system affecting the original’s price when transferring seems to contradict the initial objective of the policy. Not only should the government thoroughly review the interpretation from legalistic point of view, but also it should take into account the possible impact on the original and patient’s options.”
- Policy
- Gangnam Severance to test chloroquine preventing COVID-19
- by Lee, Tak-Sun Mar 29, 2020 11:18pm
- Gangnam Severance HospitalGangnam Severance Hospital is to conduct a research-purpose clinical trial on malaria drug hydroxychloroquine to test its preventive effect, as it is currently used on patients with COVID-19. On Mar. 25, Korea’s Ministry of Food and Drug Safety (MFDS) approved the clinical trial protocol on a ‘Study on Hydroxychloroquine’s Post-exposure Prophylaxis against SARS-CoV-2,’ submitted by Gangnam Severance Hospital. Professor Song Younggoo at Infectious Disease Department would lead the study. Unlike other clinical trials on chloroquine, the researchers would test the medicine’s preventive effect and not the treatment effect. Accordingly, the study participants would not be the confirmed cases, but people who came in contact with a confirmed patient, regardless of showing symptoms. The participants would be eligible for the study only within 72 hours since their contact with confirmed patient. The protocol calls for total 2,486 participants. Lasting until March next year, the study would use Hanlim Pharm’s Haloxin as a trial drug. The investigators would confirm the infection conversion rate of COVID-19 by confirming the participants' negative infection test first before the administration of the drug and testing them again 14 days after the exposure. Both tests would use polymerase chain reaction (PCR) test. Prior to the latest approval, Asan Medical Center also received an approval for a hydroxychloroquine clinical trial. But Asan Medical Center is testing the medicine’s treatment effect in patients with COVID-19.
- Policy
- “Lowest A7 price for latecommer PE-exempted RSA drug”
- by Lee, Hye-Kyung Mar 29, 2020 11:18pm
- When a first-in-class drug is listed with risk sharing agreement (RSA), a follow-on pharmacoeconomic evaluation (PE)-exempted drug would be reviewed for reimbursement feasibility with price higher than the lowest A7-adjusted price. And the revised review criteria added a phrase, ‘only referring to drugs with public health insurance reimbursement in foreign countries or equivalent level of coverage,’ for reviewing international adjusted average price based on overseas reimbursement listing status. Korea’s Health Insurance Review and Assessment Service (HIRA) is accepting public opinion for 80 days until June 11 on the revised ‘Review Criteria on New Drug and Negotiating Drugs’ with the said changes. The review criteria has been set to provide basis for the Article 11-2 of Rules on National Health Insurance Reimbursement Standard, the Article 7 of Pharmaceutical Decision and Adjustment Standards and the Article 4 of Regulation on Pharmaceutical Reimbursement Listing Evaluation Standard and Procedure. The revised notice preannounced by Ministry of Health and Welfare (MOHW) includes details of applying RSA on follow-on drugs, which HIRA has specified by setting down ‘Evaluation Criteria on Drugs Applied with Manufacturer’s Compliance Terms (RSA).’ For RSA eligible drug groups, MOHW has included drugs exempted from PE data submission among drugs reviewed as cost-effective for reimbursement. HIRA defined drugs that fall under ‘the Article 6-2 of Regulation on Pharmaceutical Reimbursement Listing Evaluation Standard and Procedure’ are the RSA applicable subjects. These drugs could be subject to RSA when qualifying conditions with their main indications. But, even drugs qualifying with additional indication could be applicable as well, if the main indication has been verified as cost-effective. The standard of a ‘main’ indication depends on the patient size. One of the PE exemption conditions, ‘the committee evaluates the subject patient size is too limited for evidence development,’ is decided based on the reimbursement beneficiary patient size (within Korea) and projected patient size status. Regardless of the Article 6-2, a reimbursement-seeking follow-on drug with treatment level equivalent to first-in-class PE-exempted RSA drug would follow the evaluation criteria and post-management standards of the first-in-class drug. These drugs’ pricing would be decided based on the lowest of adjusted price from A7 countries (the U.S., the U.K., Germany, France, Italy, Switzerland and Japan). The labeled price for the refund type RSA would be decided considering the price offered by the pharmaceutical company, and the offered price should be higher than the lowest A7 adjusted price. But in case the estimated selling price (actual price) offered by the company is higher than the evaluation standard price, the company may offer unit cost of the applicant drug taking the lowest A7-adjusted price into account. A Korean-developed drug approved first time in the world in Korea, with reimbursement listing in three A7 countries, would be priced considering lowest A7-adjusted price of a same-class drug, and the ones with listing in less than three A7 countries would receive price decided by Drug Reimbursement Evaluation Committee (DREC) based on 10 percent premium on the highest price of alternative drug and external adjusted price of same-class drug. A phrase stating ‘only referring to drugs with public health insurance reimbursement in foreign countries or equivalent level of coverage’ has been added to the definition of foreign adjusted average price, as a part of overseas listing status evaluation criteria.
- Policy
- “NA should stop loosening new drug regulation”
- by Lee, Jeong-Hwan Mar 29, 2020 11:17pm
- Prior to the upcoming general election, health related civic groups are voicing out to the National Assembly (NA) about their disapproval on over-the-counter (OTC) drug sold outside of pharmacy and profit-making pharmacy. The groups urged the lawmakers to establish public pharmaceutical company, learning from COVID-19 outbreak, and stop alleviating pharmaceutical regulations, and also to reinforce public infrastructure of healthcare human resources by expanding the share of public healthcare institutes up to 30 percent. On Mar. 24, the Free Healthcare Campaign Center convened a press conference in front of the NA to demand public health expansion policies for the general election. The Campaign Center has reprehended the ruling and opposition parties for not setting forth policies regarding new infectious disease responding public health improvement and financial support to overcome life-threatening disaster when COVID-19 is spreading and April general election is approaching. The organization pointed out that most of political parties are neglecting the voters’ needs when the election is to be held amid the global catastrophe. Specifically, the organization demanded the NA to secure the share of public healthcare institute at least up to 30 percent to protect the lives of the people from highly detrimental infectious disease like COVID-19. The Campaign Center official stated, “As a start, the NA should open public healthcare clinics in Daejeon, Gwangju, Ulsan and Western Gyeongnam Provicne, buyout Cheongdo Dae Nam Hospital and Busan Wallace Memorial Baptist Hospital and make Daegu Dongsan Hospital public.” “Although a political party claims infectious disease specializing hospitals should be opened, the special hospital would eventually follow the footsteps of Ajou University Hospital Trauma and Acute Care Surgery Division,” the official added. The officials explained the government should hire doctors and nurses as public health infrastructure for the public healthcare institutes. And the organization appealed the necessity of mandatory service of medical professionals at public healthcare institutes by passing a bill on establishing public medical school. The Campaign Center demanded for a financial support, such as sickness benefit, and temporarily lessened medical expense in case of disaster. The organization argues Korea should also implement the sickness benefit policy as most of OECD member countries provide income security when treated from public health insurance. They explained it would provide more practical support if paid leaves are given institutionally and layoff is banned during COVID-19, like in other countries Moreover, the officials demanded the government to significantly reduce copayment rate to allow the people to use medical care sufficiently, despite economic recession and income cut. More specifically, the Campaign Center demanded for public pharmaceutical company. COVID-19 vaccine has unclear prospects in profit making and return on investment. And a public pharmaceutical company should take over the job as private companies are reluctant about the vaccine production. The officials also stressed again the government should stop alleviating pharmaceutical regulations, such as the Cutting-edge Regenerative Medicine Act. The official urged, “Even the distribution of over-the-counter and essential drugs would struggle as pharmaceutical exports are restricted due to the outbreak,” and “to stabilize production of essential drugs crucial to public health management, public pharmaceutical company is necessary.” “While incidents like fake drug Invossa is happening, the NA has passed the Cutting-edge Regenerative Medicine Act that loosens safety regulations on genetic treatment and stem cell treatments. It is a law that approves drugs so easily, regardless of clinical trial process. And OTC sales should not be allowed outside of pharmacy and legislating profit-making pharmacy should be dropped,” the official added.
- Opinion
- [Reporter’s view] Social distance is urgently needed
- by Lee, Hye-Kyung Mar 29, 2020 11:17pm
- The government has nailed down the 15-day period from March 22 to April 5 as a decisive time to win the war against COVID-19. On the 21st, Prime Minister Sye-kyun Chung said, “We need a much stronger social distance” through the dialogue with the public. In fact, the government's policy is a bit late. The government emphasizes social distance, emphasized by attaching the adjective 'Much more powerful', but experts suggested social distance to prevent the spread of COVID-19 from early March. This is the Korean Medical Association's '3-1-1' campaign. The KMA proposed the first week of March as a week to get used to social distancing. According to the proposal, the government and local governments included employees who were not related to COVID-19 to consider temporary double shift jobs, but the campaign was useless. I wonder if it would have been like if the government had taken the opinions of experts at that time and set the current policy. The social distance campaign has made a detour. However, even if it is late, it is impossible to give up social distance. Beginning April 6th, elementary, middle and high schools will start. Universities that started classes with online lectures are also planning to conduct offline classes after April 6. As the movement that cannot be stopped by social distance begins, the next 15 days is a deadline that can prevent the spread of COVID-19 in the future. The government's strong recommendations will keep the people disciplined. The following are recommendations given to the national dialogue. Religious facilities, indoor sports facilities, and entertainment facilities are to be discontinued. If inevitable, it is necessary to observe the regulations for each type of facility and to refrain from using the multi-use facilities for 15 days. The refrain from using a multi-use facility means that you must refrain from going outside except purchasing daily necessities, and postpone or cancel private group meetings, appointments, and trips. “The 15 days” is an inflection point to prepare for a new life against COVID-19. In the meantime, with the timid excuse that there was no strong recommendation from the government, I hope that this will be different from this. On the day of the announcement of the prime minister's talk, I also canceled the appointments full on the cell phone scheduler with 'I'm sorry' one by one. The weekly Pilates was also postponed for two weeks. I hope that everyone will give up their selfish thoughts, and everyone will join the social distance campaign for the 15 days, win the war against COVID-19 and return to our daily lives.
- Company
- Novartis vs. Hanmi: Galvus generic to ignite legal dispute
- by Eo, Yun-Ho Mar 26, 2020 06:12am
- A conflict between Novartis and Hanmi Pharmaceutical is expected to deepen over the generic of the DDP-4 inhibitor Galvus. Novartis Korea is apparently preparing legal actions against Korean pharmaceutical companies attempting to evade patent infringement on Galvus (vildagliptin) by excluding one indication. The legal dispute over the patent would begin from next month as the reimbursement listing on Hanmi Pharmaceutical’s generic ‘Vildagle’ has been decided recently. Hanmi Pharmaceutical won an approval in January on four of indications of the original Galvus, except for the indication to treat a patient unable to control blood sugar level sufficiently with metformin monotherapy. The patent on the last indication is to expire in August 2021. Hanmi Pharmaceutical has requested negative confirmation of scope on the rest of the patents in last December to the Intellectual Property Trial and Appeal Board. The confirmation is still in process. Within the industry, the patent evading strategy has been used previously. Chong Kun Dang has launched a generic Dutesmol before the extended patent term of the original benign prostate hyperplasia and hair loss treatment Avodart (dutasteride) by GSK was expired. But according to Novartis, Galvus’ case is different from the precedent. Unlike Avodart with two contrasting indications of treating benign prostate hyperplasia and hair loss, all indications of Galvus are commonly treating type 2 diabetes. So evading infringement of extended patent term by dropping one indication would be unfeasible. Moreover, it would be impossible to confirm an off-label prescription of the generic for the patented indication as the Korean medical field only gives one prescription code on each disease. And Novartis has warned of forthcoming legal action against the Korean company. Novartis official stated, “The company sees this matter seriously and if the reimbursed Vildagle is to push on with the launch schedule before the patent expires, the company would take all possible legal actions including sales ban. Patent and intellectual property is the driving force of new drug development and pharmaceutical industry’s future advancement.” Regarding the issue, Hanmi Pharmaceutical official stated, “The official release date for Vildagle has not been set due to the COVID-19 outbreak. But the company would do everything to improve patient’s access to treatment and to relieve patients from financial burden by providing high quality generic to them.”
- Policy
- Saxenda's misuse and abuse are discussed
- by Lee, Tak-Sun Mar 26, 2020 06:12am
- Self-injecting agent used for the purpose of weight loss The Ministry of Food and Drug Safety plans to release and disclose self-injection system safety management measures such as 'Saxenda', which has recently increased in sales volume as a weight management supplement. However, in the course of the discussion, there was still a large difference in opinion between doctors and pharmacists. Patients do not abuse, and agree to strengthen education to use properly, and disagreements have emerged among educational subjects.. The Ministry of Food and Drug Safety is unlikely to be a government agency that can determine the number of divisions or increases in the discussion process, so it is expected to draw a final focus on strengthening patient education. The Ministry of Food and Drug Safety (MFDA) plans to deliberate and write a consultation on the adequacy and validity of the measures to support the safe use of biopharmaceutical self-injection drugs from the 30th to April 3rd. Through this, the policy is to prepare a final draft. Previously, Minutes of the Central Pharmaceutical Affairs Council held in January were also released. Specialists representing representatives of doctors and pharmacists and experts from consumer organizations also attended the meeting. At the meeting, it was said that they agreed to the direction of measures to support the safe use of self-injection drugs. The main content is strengthening education such as directions. However, there was a disagreement between the representatives of physicians and pharmacists over the subject of education. A doctors' group official argued that the hospital should be the center of education, while a pharmacist's group said that the pharmacy should be the educational subject. As pharmacies strengthened their education, it was also suggested that fundamental problems, such as mandatory outpatient’s prescription of self-injection and increase in pharmaceutical charge, should also be considered. Another opinion is that patients should be trained in the hospital for initial treatment and in the pharmacy during continuous treatment. In the end, they all acknowledged the need to strengthen education so that patients could use self-injection. However, there is a slight disagreement over the subject of education because the self-injection system is an exception in the current system of separation of prescribing and dispensing drugs, 'Getting treatment to doctors, dispense to pharmacists'. Saxenda is an injection, but because it can be used by patients outside the hospital, it is also sold in hospitals and in pharmacies. Moreover, as it is used for cosmetic purposes such as weight loss, side effects caused by misuse have also been raised. In the last year's parliamentary assembly, the issue was raised, and there was also an opinion that self-injection prescriptions should be mandatory for outpatient’s prescription. Accordingly, the Ministry of Food and Drug Safety (MFDS) announced that it will prepare measures for abuse and correct use of patients. An official from the Ministry of Food and Drug Safety said, "We are looking for ways to focus on strengthening education within a framework that can be used correctly without abuse by the patient, and plan to make a final plan in the near future through expert opinion". The MFDS is expected to come up with a plan to strengthen video education and practice education with usage, expand public awareness of misuse, strengthen crackdown on illegal advertising violations, and check illegal distribution. However, It is clear that the mandatory outpatient prescription (separation of prescribing and dispensing drugs) and the increase in pharmaceutical charge are not included in the management of the MFDS. In the end, even if the Ministry of Food and Drug Affairs comes out, it is expected that the conflict between physicians and pharmacists will continue despite the subject of sales and guidance of self-injection.
- Policy
- Domestic drugs, access to the Chilean procurement market
- by Lee, Tak-Sun Mar 26, 2020 06:11am
- The KHIDI (Director Deok-cheol Kwon) announced that it has signed a Memorandum of Understanding (MOU) with Chile's Health Procurement Service (CENABAST, Valentin Diaz Gracia, Chief Executive Officer) and Korean companies to advance into public procurement of pharmaceuticals in Chile. The Chilean Health Procurement Authority (CENABAST) manages the public procurement of all medicines and medical devices in Chile and supplies them to public health institutions. Through the signing of this Memorandum of Understanding, the two sides agreed to ▲discover excellent Korean companies that meet procurement needs ▲sign an export contract with the Korean Corporate and CENABAST ▲actively support and cooperate with Korean companies to obtain approval from the Chilean Public Health Service( Instituto de Salud Pública, ISP). In particular, it is said that through this cooperation, products that have not been approved for marketing in Chile can participate in procurement through the preparation of required documents if they have a Korean marketing license. It is said that cooperation with the CENABAST has made it possible to enter the market more quickly. The signing of the Memorandum of Understanding was promoted on the basis of cooperation between the two countries' Ministry of Health (G2G), and the signing of the Memorandum of Understanding between the Ministry of Health and the Republic of Korea in 2015 became an important foundation, the KHIDI said. The Memorandum of Understanding between the Ministry of Health is based on information exchange and joint project cooperation to promote mutual cooperation in areas of common interest, such as health care policy, pharmaceutical and medical device cooperation, and aging. Meanwhile, the KHIDI signed a three-way agreement with the KPBMA (Chairman Hee-mok Won) and the Korea Pharmaceutical Traders Association (Chairman Jang-suk Oh), and plans to cooperate to find companies and derive results to expand the domestic pharmaceutical industry into the Chilean market. To cooperate. It is expected that the agreement will accelerate Korean companies' entry into Chile. Chile has a market of $4.2 billion in pharmaceuticals last year. In addition, the CENABAST's public procurement purchases amounted to $1 billion, of which pharmaceutical products accounted for 84.2%, the highest at $ 850 million. The government's medical spending is expected to continue to increase due to the increased incidence of chronic diseases in Chile, the aging population, and the expansion of access to healthcare services to improve health care. Chile's major importers of pharmaceuticals are the United States, Germany, France and India, and Korea ranks 28th in the total import market. Korean companies such as Daewoong, Korea United Pharm, Green Cross, Daewon Pharmaceutical, Samjin Pharm, Ildong Pharmaceutical, and Boryung have exported biosimilars, anti-cancer drugs, and pharmaceuticals to Chile.
- Policy
- Sanofi’s new laxative line-up DulcoSoft approved in Korea
- by Lee, Tak-Sun Mar 26, 2020 06:11am
- The world’s top-selling constipation treating drug brand ‘Dulcolax’ The world’s leading constipation relief Dulcolax maker Sanofi is expanding the brand line-up. The global company means to consolidate the leadership in the competitive Korean laxative market with new oral solution. On Mar. 23, Sanofi-Aventis Korea has received Ministry of Food and Drug Safety’s (MFDS) approval on DulcoSoft powder (macrogol 4000). In the market, there are two other products with macrogol 400. The non-absorbable osmotic laxative medicine improves defecation by increasing the volume of intestinal fluids to the stools. Macrogol 4000 is widely used in over-the-counter laxative for chronic constipation. Currently Ahn-gook Pharmaceutical’s Forlax powder and Ipsen Korea’s Ipsen Macrogol 4000 powder are two other macrogol 4000 medications approved in Korea. DulcoSoft was actually released once in Korea as an offshoot of Dulcolax brand. Before Sanofi acquired Dulcolax from Boehringer Ingelheim, it was launched in Korean market in 2009. Since Sanofi took over Dulcolax in 2016, Dulcolax-S enteric coating tablet (docusate sodium, bisacodyl) and Dulcolax suppositories (bisacodyl) are available in Korea at the moment. Dulcolax is the world’s top-selling chronic constipation treatment. According to global healthcare consulting firm Nicholas Hall, Dulcolax was the most sold laxative in 2018. Since the release in 1953, Dulcolax has been sold in over hundred countries. The laxative was introduced to the Korean market in 1976, and it has been leading the market for over 17 years. Sanofi says 5.2 packages were sold per minute in 2018. Pharmaceutical market research firm IQVIA found Dulcolax has generated over 13.1 billion won in Korea last year. It topped the market easily putting aside other competitors like Mayqueen-Q by Myung In Pharmaceutical (5.2 billion won), Bicogreen S by Kolon Pharma (2.5 billion won) and Alaxyl by Bukwang Pharm (1.9 billion won). However, the industry experts see that well-known brand name is not enough to defend the title as many laxative makers are aggressively marketing their products. Sanofi’s intention is to add a new line-up to secure the market share. DulcoSoft is recommended to adults and children aged eight years and over. It can be taken one or two sachets dissolved in a liquid to take once-daily, but for children, one sachet in two days is recommended depending on symptoms. The benefits occur within one or two days. However, children should not take the medication for more than three months.
