FDA Officials OK New Generic Valsartan – APhA submits compounding comments to FDA. – (866) 348-2889.
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.