Biopharmaceuticals Valsartan Hydrochlorothiazide Tablets Approved for Listing! The first company to pass the consistency evaluation

On February 13, the Valsartan hydrochlorothiazide tablets (cyhs1800102) declared by Baiao Pharmaceutical Co., Ltd according to the new four categories were approved by the State Food and Drug Administration for listing, which was deemed to have passed the consistency evaluation, and the State Food and drug administration has arranged to issue the drug approval documents This is another large-scale antihypertensive drug obtained by Baiao pharmaceutical industry after the approval of valsartan amlodipine tablets, the first imitation of valsartan tablets, on February 5 Co Diovan, the original drug of valsartan hydrochlorothiazide tablets, was developed by Novartis It is a single compound antihypertensive drug composed of valsartan and hydrochlorothiazide, an angiotension receptor antagonist (ARB) It is mainly used for the treatment of mild to moderate essential hypertension, which can not be fully controlled by a single drug It was first listed in 1998 Before that, six domestic enterprises had been listed to sell valsartan hydrochlorothiazide tablets, and Baiao pharmaceutical industry became the first enterprise that passed the consistency evaluation of the product Source: pharmago After Baiao pharmaceutical, at present, only CR Secco has submitted the supplementary application of "consistency evaluation" in November 2019, and other relevant listed enterprises have completed the be test, but no application for consistency evaluation has been submitted Application for consistency evaluation of valsartan hydrochlorothiazide tablets Completion of be test of valsartan hydrochlorothiazide tablets Source: pharmago For patients with hypertension, compared with single mechanism antihypertensive drugs or free combination of different mechanism antihypertensive drugs, single compound drugs not only have obvious advantages in antihypertensive efficacy, prevention of cardiovascular and cerebrovascular complications, and reduction of adverse reactions, but also can effectively reduce the proportion of drug missed and improve compliance In recent years, European, American, Japanese and other countries have successively updated hypertension management guidelines to recommend single-chip compound antihypertensive preparations more and more At present, the domestic commonly used single-chip compound antihypertensive drugs include valsartan hydrochlorothiazide tablets, valsartan amlodipine tablets (I), irbesartan hydrochlorothiazide tablets, losartan hydrochlorothiazide, etc Novartis' valsartan hydrochlorothiazide tablets and valsartan amlodipine tablets are the basic drugs for clinical hypotensive treatment, with a wide range of applications Even after the patent period expires in 2019, they still have a total sales revenue of about 2.1 billion US dollars Source: pharmago