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Today, the US Food and Drug Administration has approved a new generic Diovan (valsartan). Valsartan is an angiotensin II receptor antagonist (ARB) that treats high blood pressure and heart failure. The FDA has given priority to reviewing this drug claim in order to address the recent shortage of this essential drug following multiple recalls of generic products to valsartan from multiple manufacturers, due to the discovery that some lots of valsartan and other ARB drugs contain impurities of nitrosamine.
"We know that ongoing recalls to prevent certain lots of valsartan containing unacceptable limits of impurities from reaching patients have resulted in a shortage of these important drugs," said FDA Commissioner Scott Gottlieb, MD. shortages, we have prioritized consideration of generic applications of these valsartan-based products. Faced with a shortage of drugs, the FDA uses a number of strategies to mitigate the effects of the shortage on patients. As part of this work, we are examining areas where we may be able to prioritize the review of generic applications waiting for the drug in short supply or similar products. We hope that today's approval of this new generic will help reduce the shortage of valsartan and we remain committed to implementing measures to prevent the formation of these impurities in drug product manufacturing processes. existing and future. We will continue to work with manufacturers so that more drugs like valsartan, belonging to a class of drugs called angiotensin II receptor blockers, can be approved without nitrosamine impurities in order to continue to address the shortage that is currently rife. "
Since last summer, the FDA has conducted an extensive investigation into the presence of nitrosamine impurities in some generic BRA products. The FDA has worked with companies to quickly eliminate all products containing unacceptable impurities from the US market, and continues to evaluate other AROs to ensure that they do not contain impurities. FDA scientists have made significant progress in understanding how these impurities can form during the manufacturing process and the agency is working with international drug regulatory agencies to make available new test methods. The FDA has also hired drug manufacturers and helped facilitate manufacturing process changes to ensure that ARBs do not contain detectable levels of nitrosamine impurities. Now that this risk is identified, the agency is setting new requirements to protect itself from the development of these impurities in drugs.
In the event of serious shortages of critical drugs, including valsartan and losartan, the FDA plays an important role in reducing these problems. For example, the FDA may expedite the review of a new or generic drug claim that, if approved, can help mitigate or prevent such a shortage and, in doing so, give priority to these. inspections and exams. The agency also works closely with manufacturers to see if they can produce additional stocks of these drugs. FDA scientists use the information from its survey to evaluate all current ARAs on the market. They will also use them when assessing future applications to ensure that the manufacturing process can not form these impurities.
For this approval, the FDA evaluated the company's manufacturing processes and also ensured that it was using appropriate test methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA. The FDA's assessment of the product manufacturing processes determined that there was no known risk of formation of other nitrosamine impurities.
The FDA continues to investigate ARB drugs containing nitrosamine impurities that do not meet the agency's quality standards. The agency will continue to update lists on the FDA website of recalled products from valsartan, losartan and irbesartan as new information becomes available based on ongoing trials. If patients are taking an ARB medication, they should consult the lists periodically as the information may change. All ARA drugs have not been recalled.
According to the National Heart, Lung, and Blood Institute, high blood pressure is a common condition in which blood travels through blood vessels, or arteries, at above normal pressures. Heart failure is a condition in which the heart can not pump enough blood to meet the needs of the body.
The most common side effects associated with valsartan are dizziness, hypotension, elevated potassium levels in the blood (hyperkalemia) and increased creatinine levels in the blood.
Today's approval of Diovan's new generic drug has been awarded to Alkem Laboratories Limited.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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