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Amosartan, The 1st approval as the initial therapy among CCB+ARB hypertension Combo Drugs08, Jul. 2010

Amosartan, achieved extended approval from KFDA as an initial therapy for the treatment of severe hypertension patients. This is the first case among hypertension combination drugs in CCB + ARB class.

 

For the approval, Hanmi has performed the phase3 trial of Amosartan from May 2009 and proved superior blood pressure management over amlodipine monotherapy. With the approval of new therapeutic usage, Amosartan now can be selected as a primary prescription option for patients with blood pressure greater than 160/100 mmHg.

 

Since its primary approval in 2009, Amosartan has been prescribed as the secondary therapy for the patients without satisfactory improvement in lowering blood pressure with amlodipine or losartan monotherapies. Even with the limited usage, Amosartan grew as one of the best selling drugs in Korean hypertention market.

 

Amosartan is the combination drug of amlodipine camsylate and losartan potassium developed and launched by Hanmi. Previously in 2009, Hanmi signed on a licensing/co-promotion agreement covering several Asian countries with MSD.

 

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