valsartan

US Food & Drug Administration News: FDA approves a new generic valsartan

Agency prioritizing review of ARB applications to help mitigate shortage of valsartan SILVER SPRING, MD (STL.News) – The U.S. Food and Drug Administration approved a new generic of Diovan (valsartan).  Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.  The FDA prioritized the review of this drug application … Continue reading US Food & Drug Administration News: FDA approves a new generic valsartan

FDA News: FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

SILVER SPRING, MD – The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly … Continue reading FDA News: FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

U.S. Food & Drug Administration News: FDA provides update on its ongoing investigation into valsartan products

WASHINGTON – The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recall of several drug products containing the active pharmaceutical ingredient (API) valsartan, used to treat high blood pressure and heart failure. The FDA’s latest testing of products shows an additional unexpected impurity in three … Continue reading U.S. Food & Drug Administration News: FDA provides update on its ongoing investigation into valsartan products

FDA News: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

SILVER SPRINGS, MD – The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.  This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled … Continue reading FDA News: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity