FDA Officials OK New Generic Valsartan

Since last summer, the FDA has worked with companies to take swift action to remove any products with unacceptable impurities from the US market

Officials with the US Food and Drug Administration have approved a new generic of Diovan (valsartan), to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers. The recalls were prompted by a finding that certain lots of valsartan and other angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities.

For this approval, which was granted to Alkem Laboratories Limited, FDA officials gave a priority evaluation to the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that this valsartan product does not contain nitrosamine impurities.

Since last summer, the FDA has worked with companies to take swift action to remove any products with unacceptable impurities from the US market, and continues evaluating other ARBs to ensure they are free of impurities. 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.

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.

“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. “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.”

The most common side effects associated with valsartan are dizziness, hypotension, high levels of potassium in the blood (hyperkalemia) and increased blood creatinine.