The identification of nitrosamine impurities in some drug products has prompted manufacturers to recall the products over concerns about the carcinogenic properties of nitrosamines. Agencies and manufacturers are evaluating the risks and chemistry of the drug products to find a solution to the contamination.   Introduction Valsartan (Diovan) is an important first-line therapy for hypertension and congestive heart failure. It also lowers the risk of death after myoc...

An immediately effective guidance from the US Food and Drug Administration (FDA) details steps to be taken to detect and prevent the introduction of potentially carcinogenic nitrosamine impurities into finished drug products and active pharmaceutical ingredients.   “The recent unexpected finding of nitrosamine impurities, many of which are probable or possible human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, metformin, rifam...

As potentially cancer-causing impurities have been identified in some blood pressure and heartburn medicines, the European Medicines Agency (EMA) is outlining a three-step process whereby manufacturers can identify and control nitrosamine impurities, including N-nitrosodimethylamine (NDMA). EMA on Monday released new templates for manufacturers to complete as part of their risk evaluations and confirmatory testing. By 26 April 2020, EMA is calling on companies to conduc...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus. EMA said that preliminary data suggest the vaccine is effective in the current Ebola outbreak in the De...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA Expands Nitrosamines Investigation to All Chemically Synthesized APIs   The European Medicines Agency (EMA) has asked manufacturers of medicines made with chemically synthesized active pharmaceutical ingredients (APIs) to test their products for nitrosamines. EMA’s request follows the discovery of the carcinogenic contaminants outside the sartan class of drugs. ...

The US Food and Drug Administration (FDA) on Friday announced that Indian drugmaker Hetero Labs is recalling 87 lots of losartan tablets distributed by Camber Pharmaceuticals after testing found the drugs contained a potentially carcinogenic impurity, N-Nitroso-N-methyl-4 aminobutyric acid (NMBA).   The recall is the latest in a series of recalls tied to the discovery of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs in the last year.   Previ...