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Photo courtesy of Yonhap News |
[Alpha Biz= Paul Lee] South Korea’s Ministry of Food and Drug Safety (MFDS) has recommended discontinuing the use of sulglycotide-based gastrointestinal drugs after they failed to demonstrate efficacy in a post-market reevaluation.
The MFDS said it distributed a safety notice on Wednesday advising healthcare professionals to stop using sulglycotide products for the treatment of gastric and duodenal ulcers and gastritis, and to switch to alternative medications. The measure applies to Samil Pharmaceutical’s product Gliptide Tablets 200 mg.
Following a review of submitted data and consultations with the Central Pharmaceutical Affairs Council, the regulator concluded that while no safety concerns were identified, the drug failed to prove its therapeutic effectiveness in domestic clinical trials.
The MFDS urged doctors and pharmacists to prescribe and dispense alternative treatments and advised patients to consult healthcare professionals for appropriate options. The notice was also shared with related agencies, including the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service.
Alphabiz Reporter Paul Lee(hoondork1977@alphabiz.co.kr)
