Posted from: Monday, April 08, 2019 - 03:55 PM - Present

New Generic for Diovan Approved

March 13, 2019 – The U.S. FDA has approved Alkem Laboratories’ generic for Novartis’s Diovan (valsartan). According to a press release, the agency prioritized review of this medication in an effort to address drug shortages caused by ongoing recalls of other valsartan generics due to nitrosamine impurities.

As part of the FDA’s review of Alkem Laboratories’ generic for approval, the agency evaluated manufacturing processes and testing protocols to ensure the product does not contain either NDMA or NDEA, both of which have been the cause of prior valsartan recalls.

Recommended dosing with valsartan depends on individual patient factors, including age and indication. The product is indicated to treat hypertension (high blood pressure) and heart failure, as well as to reduce cardiovascular mortality in clinically stable patients following myocardial infarction (a heart attack). A black box warning cautions that valsartan can cause embryo-fetal toxicity.

Launch and pricing plans have not been made available.

Last Updated Monday, October 21, 2019 - 06:18 PM.