BRIEF—China approves first generic Exforge

7 February 2020

China’s medicines regulator has granted approval for the country's first generic version of Swiss pharma giant Novartis' hypertension drug Exforge (amlodipine and valsartan).

Exforge is available in two dosage forms in China - 5/80mg and 5/160mg.

The generic version, supplied by Beijing-based Baiao Pharmaceuticals, is the 5/80mg form.

Six other manufacturers have also filed marketing applications for generic versions of Exforge, among which are Hengrui and Huahai.

Amlodipine and valsartan is the only fixed-dose combination tablet for hypertension covered by China's national drug reimbursement list.



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