FDA Okays New Generic Version of Valsartan To Curb Shortage

FDA Okays New Generic Version of Valsartan To Curb Shortage

Introduction

On March 12, the Food and Drug Administration (FDA) approved a new generic version of valsartan (Diovan) to ease the recent shortage of blood pressure medicine owing to a series of safety recalls.

Scott Gottlieb, FDA Commissioner, told the valsartan recalls were the result of the findings that the drug was contaminated with nitrosamine impurities, and the agency reviewed the applications for new generic versions on priority to overcome the sudden shortage. The drug's brand version Diovan has not been recalled. The FDA evaluated Alkem Laboratories Ltd.'s manufacturing and testing reports to ensure the new generic valsartan was free from impurities found in the recalled medications. Gottlieb said, "we  remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products." There have been more than 15 safety-recalls of generic versions of popular blood pressure and heart failure medications such as valsartan, losartan, and irbesartan due to traces of carcinogenic impurities in them.

The FDA is still investigating the drugs belonging to the angiotensin II receptor blocker (ARB) class that contains nitrosamine impurities and fails to meet the agency's quality standards. Patients on ARB can periodically visit the FDA's website to check the lists of recalled medications, which are updated frequently.