"We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines," said FDA Commissioner Scott Gottlieb, M.D. "So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products. When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. As part of that work, we look at where we may be able to prioritize review of pending generic applications of the medicine in shortage, or similar products. 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. We’ll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage."
Since last summer, the FDA has conducted a major investigation to address the presence of nitrosamine impurities in certain generic ARB products. The FDA has worked with companies to take swift action to remove any products with unacceptable impurities from the U.S. market, and continues evaluating other ARBs to ensure they are free of impurities. FDA scientists have made important strides in understanding how these impurities may form during the manufacturing process and the agency is working with international drug regulatory agencies to make new testing methods available. The FDA has also engaged drug manufacturers and helped facilitate manufacturing process changes to ensure ARBs are free of detectable levels of nitrosamine impurities. Now that this risk has been identified, the agency is implementing new requirements to guard against the development of these impurities in drugs.
In cases of severe shortages of critical medications, including the ongoing shortage of valsartan and now losartan products, the FDA plays an important role in mitigating these challenges. For example, the FDA can expedite review of a new or generic drug application that, if approved, may help mitigate or prevent such a shortage and to do so, prioritizes these inspections and reviews. The agency is also working closely with manufacturers to see if they can produce additional supplies of these medicines. FDA scientists are using the information learned from its investigation to evaluate all ARBs currently on the market and will also apply this information when assessing future applications to ensure that the manufacturing process can't form these impurities.
For this approval, the FDA evaluated the company's manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA. The FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.
The FDA continues to investigate ARB medicines that contain nitrosamine impurities and that do not meet the agency's quality standards. The agency will continue to update the lists on FDA's website of recalled valsartan, losartan and irbesartan products as more information becomes available from ongoing testing. If patients take an ARB drug product, they should check the lists periodically, as information may change. Not all ARB medicines have been recalled.
According to the National Heart, Lung, and Blood Institute, high blood pressure is a common disease in which blood flows through blood vessels, or arteries, at higher than normal pressures. Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs.
The most common side effects associated with valsartan are dizziness, hypotension, high levels of potassium in the blood (hyperkalemia) and increased blood creatinine.
Today's approval of the new generic of Diovan was granted to Alkem Laboratories Limited.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.