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Regulator to reclassify dermatological cream Lidomex as prescription drug
  • By Kim Yun-mi
  • Published 2020.07.08 11:24
  • Updated 2020.07.08 11:24
  • comments 0

The drug regulator said it would reclassify dermatological treatments, including Lidomex that contain prednisolone valero acetate 0.3 percent, as prescription drugs.

The decision came after the Supreme Court ruled on May 18 in favor of Sama Pharm, which requested the nullification of the government’s refusal to change the status of Lidomex from the over-the-counter (OTC) drug to prescription medicine.

Oh Jeong-won, head of the Convergence Innovative Product Support Team at the Ministry of Food and Drug Safety, said the ministry planned to reclassify drugs containing prednisolone valero acetate as prescription drugs.

Oh Jeong-won, head of the Convergence Innovative Product Support Team at the Ministry of Food and Drug Safety, told reporters in a briefing Tuesday that the ministry planned to sort out the drugs containing the same ingredient as Lidomex as prescription drugs.

The ministry has requested Sam-A Pharm to submit documents on precautions for use, as prescription drugs are required to display them.

Sam-A Pharm had requested the government to change the classification of Lidomex from the OTC drug to a prescription drug, saying the drug has a titer equivalent to corticosteroid in Grade 5 or 6.

Treatments containing corticosteroids are divided into seven grades, with 1 being the strongest. Drugs in Grade 1 to 6 need a prescription, and those in Grade 7 are classified as OTC.

Sam-A applied for the food and drug safety ministry’s reclassification of Lidomex. Still, the ministry refused to do so, citing a lack of evidence.

The drug company filed a suit against the ministry to nullify the ministry’s refusal to reclassify Lidomex. In May, the Supreme Court upheld Sam-A’s request and ended the two-year legal fight.

“We respect the Supreme Court’s verdict,” Oh said. “When OTC drugs become prescription drugs, they need to have ‘precautions for use.’ So, we asked Sam-A Pharm, as the representative company, to submit necessary documents.”

Once Lidomex meets requirements for prescription drug status, the food and drug ministry will apply the same classification to all treatments containing prednisolone 0.3 percent universally. “Manufacturers of the drugs do not have to request the change individually. Their drugs will automatically gain the prescription drug status,” Oh said.

Prednisolone, a corticosteroid, comes in various types such as cream and lotion to treat dermatological conditions, including contact dermatitis, atopic dermatitis, seborrheic dermatitis, and dry skin.

kym@docdocdoc.co.kr

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