FDA OK’s Alkem Labs’ Generic Diovan to Help Shortages

FDA has approved an Alkem Laboratories ANDA for a new generic of Diovan (valsartan), an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The agency says it prioritized the submission’s review to “help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.”

To approve the ANDA, FDA says it evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the product does not contain impurities. The agency says its “assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.”