FDA approves a new generic valsartan

April 29, 2019FDA News Release (03/12/19)

Following a number of recalls of generic valsartan products from several manufacturers, FDA approved on Tuesday a new generic of valsartan (Diovan) to treat high blood pressure and heart failure. Approval of the new generic was given to Alkem Laboratories Ltd. FDA prioritized the review to help alleviate the recent shortage of this drug in the wake of the recalls. "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, MD. He added, "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." FDA has been investigating since last summer the presence of nitrosamine impurities in certain generic angiotensin II receptor blocker products. The agency notes that for this new approval, it evaluated Alkem's manufacturing processes and verified that they used appropriate testing methods to demonstrate that the valsartan product does not contain NDMA or NDEA. "The FDA's assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities," the agency said. Valsartan treats high blood pressure and heart failure. Its most common adverse effects are dizziness, hypotension, hyperkalemia, and increased blood creatinine.

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