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New antihypertensive combos ready for market entry
  • By Lee Hye-seon
  • Published 2018.01.09 15:17
  • Updated 2018.01.09 15:17
  • comments 0

GC (formerly Green Cross) Pharma, Dongkwang Pharm, and HanAll Biopharma have recently received the regulator’s approval for their antihypertensive combination drugs to hit the market. The ingredients of the combo drugs are candesartan and amlodipine.

The Ministry of Food and Drug Safety on Monday approved the application for marketing permission for GC’s Daviroad Tab. 16/5mg, Dongkwang’s Canstar-X Tab. 16/5mg, and HanAll’s Novakhan Tab. 16/5mg.

The three drugmakers received the nod for each combo drug in 16/10mg doses on Dec. 27. Securing additional doses on Monday, the companies have completed preparations for market entry of their antihypertensive combos.

The three drugs are all incrementally modified drugs (IMD) that earned the re-evaluation period of six years. During the re-evaluation period, the companies collect data for their drugs’ safety and efficacy, while the regulator limits approval for latecomer drugs.

Doctors can use the antihypertensive combo of ARB (angiotensin receptor blocker) candesartan and CCB (calcium-channel blocker) amlodipine for patients who cannot control blood pressure by single therapy of candesartan. The combo drugs also come in a smaller size, making it convenient for patients to take.

CJ HealthCare’s Machkhan, Shinpoong Pharm’s Candeamlo, and Chong Kun Dang’s Cantabell have led the antihypertensive drug market, after their launches in 2016.

Prescriptions of the three drugs have been on the rise. Machkhan’s prescriptions amounted to 2.89 billion won ($2.71 million) during the first year of sales, followed by Cantabell with 1.79 billion won and Candeamlo with 915 million won.

lhs@docdocdoc.co.kr

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