FDA approved Valsartan Generic
The FDA approved a new generic valsartan to control blood pressure.
It was a mean to solve the problem of reduced supplies after some pharmaceutical manufacturers recalled their valsartan drugs because of the potential risk of cancer.
The FDA is reviewing the marketing application for the generic valsartan manufactured by Indian company Elkem Laboratories Ltd, prior to its approval.
The approved drug is a generic of Novartis’ Diovan original product.
The FDA chief executive officer, Scott Gottlieb, said that, given the shortage of drugs, the FDA uses a number of strategies to mitigate its effects on patients.
Mr. Gottlieb also noted that the agency has given priority to the task of reviewing marketing applications for valsartan drugs to mitigate the effects of drug shortages on the health care.
The FDA also examined the manufacturing processes at Alkem’s facilities and concluded that the company used proper analytical methods to demonstrate that the new generic does not contain potentially carcinogenic NDMA or NDEA impurities that have already caused global withdrawal of valsartan and some other sartans.