As of April 1, the FDA Drug Shortages database reported ongoing shortages of 144 drugs along with shortages of 44 others that had been resolved in recent weeks. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. 9/10/2020. Created July 17, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. 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. ... Repackagers may have some presentations affected depending on the source supplier. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. Any application of this information for any purpose shall be limited to personal, non-commercial use. As part of that work, we look at where we may be able to prioritize review of pending generic applications of the medicine in shortage, or similar products. The agency prioritized the review of this drug application to help relieve a recent shortage of the drug. ... Mylan has valsartan tablets available. Cancer. Drugs containing valsartan have been recalled because they may contain the cancer-causing impurities NDEA and NDMA. For example, the FDA can expedite review of a new or generic drug application that, if approved, may help mitigate or prevent such a shortage and to do so, prioritizes these inspections and reviews. More information on the impact level can be found in the framework for a multi-stakeholder approach to handling shortages of human medicinal products . "Currently, valsartan products are in shortage, and we know that other types of products have the potential to fall into shortage soon," an FDA statement released Thursday says. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. Approval comes in response to ARB shortage. Sep 10, 2020: Valsartan Tablets: May 29, 2020: Vancomycin Hydrochloride Injection: Jul 14, 2020: Vecuronium Bromide Injection: Aug 11, 2020: ... Drug shortages statistics, and best practices, guidelines and publications related to drug shortages Learn More. NHS England has warned of a continued shortage in the supply of the hypertension treatment valsartan. Any application of this information for any purpose shall be limited to personal, non-commercial use. This is linked to an impurity in those medications, called NDMA. Eight ARBs are sold on the United States market and there are blood pressure medications which are not ARBs which may be an appropriate valsartan substitute. A new medication can cause one’s blood pressure to react differently than it does to valsartan.Switching medications isn’t an option for some patients. The agency is also working closely with manufacturers to see if they can produce additional supplies of these medicines. 5/29/2020. Valsartan manufacturing can create NDEA and NDMA when it is done in too acidic of an environment.Properly formulated valsartan does not cause cancer. Today, the U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan and Hydrochlorothiazide Tablets. The FDA has worked with companies to take swift action to remove any products with unacceptable impurities from the U.S. market, and continues evaluating other ARBs to ensure they are free of impurities. Serious medical issues can result from discontinuing valsartan use. Not all lots of valsartan have been recalled due to contamination. Erin Fox, a drug shortage expert at the University of Utah, said, “When the F.D.A. FDA scientists have made In cases of severe shortages of critical medications, including the ongoing shortage of valsartan and now losartan products, the FDA plays an important role in mitigating these challenges. This came less than one month after the first valsartan recall due to NDMA contamination on July 16th, 2018.It appears as if the contaminated lots of valsartan which were recalled became contaminated due to manufacturing changes. The FDA is warning that there is a shortage of the commonly prescribed blood pressure drug valsartan due to ongoing manufacturing issues in which the drug is being contaminated with a possible carcinogen. "Valsartan products are in shortage, and we know that other types of products may fall into shortage soon," FDA Commissioner Dr. Scott Gottlieb and FDA director of … The Valsartan Recall List. Valsartan is an angiotensin receptor blocker, or ARB. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of “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, M.D. A series of recalls of the high blood pressure and heart failure medication have led to the shortage. You may also experience unexpected weight gain. Created July 17, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist.