New Generic Valsartan Approved

FDA Prioritizing Review of ARB Applications to Help Mitigate Drug Shortage

The FDA has approved a new generic version of Diovan (valsartan), an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine. There have been multiple recalls of generic valsartan products from several manufacturers after finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.

Since last summer, the FDA has conducted a major investigation to address the presence of nitrosamine impurities in certain generic ARB products, and continues to evaluate other ARBs to ensure that they are free of impurities. The agency has made important strides in understanding how these impurities may form during the manufacturing process and is working with international drug regulatory agencies to make new testing methods available. The FDA has also engaged drugmakers and helped facilitate manufacturing process changes to ensure that ARBs are free of detectable levels of nitrosamine impurities.

The agency is also working closely with manufacturers to see if they can produce additional supplies of these medicines. Information learned from the investigation will be used to evaluate all ARBs currently on the market and to assess future applications to ensure that the manufacturing process can’t form these impurities. For the new generic valsartan approval, the FDA evaluated the company’s manufacturing processes and also made sure it used appropriate testing methods to demonstrate that the drug does not contain NDMA or NDEA.

The FDA will continue to update its website with information about recalled valsartanlosartan and irbesartan products as more information becomes available.

The approval of the new generic of Diovan was granted to Alkem Laboratories Limited.

Source: FDA, March 12, 2019