Medication Monitor



Generic Name (Trade Name—Company)
Notes
March 13, 2019

Valsartan

(No trade name—Alkem Laboratories Limited)
FDA approves a new generic valsartan

FDA approved a new generic valsartan in response to a recent shortage resulting from multiple recalls of generic valsartan products from several manufacturers after certain lots of valsartan and other ARB medicines were found to contain nitrosamine impurities.

The agency is also working closely with manufacturers to see if they can produce additional supplies of these medications. FDA scientists are using the information learned from an 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, FDA evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the new generic valsartan does not contain NDMA or NDEA. FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.

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 its 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.

Valsartan treats high blood pressure and heart failure. Its most common adverse effects are dizziness, hypotension, hyperkalemia, and increased blood creatinine.