The Food and Drug Administration (FDA) has approved a new generic version of Diovan (Novartis) that does not contain N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), 2 potentially carcinogenic impurities identified in several recalled valsartan products.
The agency prioritized the review of the application submitted by Alkem Laboratories Limited in order to alleviate the valsartan shortage that resulted from the recall. Valsartan, an angiotensin II receptor blocker (ARB), is used to treat various cardiovascular conditions including heart failure and hypertension.
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” said FDA Commissioner Scott Gottlieb, MD.
In addition to valsartan, other ARB medications, including irbesartan and losartan, have been recalled due to impurities resulting from certain chemicals and reaction conditions during the manufacturing process of the active pharmaceutical ingredients (API). In a press statement, Dr Gottlieb noted that the FDA plans to prioritize the review of ARB applications in order to help mitigate the effects of the shortage on patients.
Information on the ongoing recalls can be found here.
For more information visit FDA.gov.