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FDA approves new generic valsartan; Alkem Laboratories bags the grant

Today, the U.S. Food and Drug Administration has approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.

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

The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result ofmultiple recallsof generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.

“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 CommissionerScott Gottlieb, M.D. “So, to address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products. When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. 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. 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. We'll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage.”

Since last summer, the FDA has conducted a major investigation to address the presence of nitrosamine impurities in certain generic ARB products. 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. FDA scientists have madeimportant strides in understanding how these impurities may form during the manufacturing process and the agency is working with international drug regulatory agencies to make new testing methods available. The FDA has also engaged drug manufacturers and helped facilitate manufacturing process changes to ensure ARBs are free of detectable levels of nitrosamine impurities. Now that this risk has been identified, the agency is implementing new requirements to guard against the development of these impurities in drugs.

In the press statement the agency has further explained that in cases of severe shortages of critical medications, including the ongoing shortage of valsartan and now losartan products, the FDA has an important role in mitigating these challenges. 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.The agency is also working closely with manufacturers to see if they can produce additional supplies of these medicines. FDA scientists are using the information learned from its investigation to evaluate all ARBs currently on the market and will also apply this information when assessing future applications to ensure that the manufacturing process can't form these impurities.

For this approval, the FDA evaluated the company's manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today 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.

U.S. Food and Drug Administration has approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.

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