When is generic diovan coming out

Recalls on Diovan valsartan began last July when the FDA detected trace amounts of a probable carcinogen in certain lots of the blood pressure drug.

The drug is an angiotensin II receptor blocker that treats high blood pressure as well as heart failure. The approval comes after months of recalls for lots of valsartan that were found to contain traces of N- nitrosodimethylamine NDMA , which has been called a probably human carcinogen. The valsartan recalls began in July , when 80 lots of Diovan were recalled due to the detection of trace amounts of impurities. There have also been recalls of other angiotensin II receptor blockers, including irbesartan and losartan.

Gottlieb, who recently announced his impending resignation from the FDA , added that the FDA has prioritized the review of generic applications for valsartan products due to the shortages caused by the recalls.

Food and Drug Administration approved a new generic of Diovan valsartan. Valsartan is an angiotensin II receptor blocker ARB that treats high blood pressure and heart failure. The FDA prioritized the review of this drug application 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.

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. 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. FDA scientists have made important 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 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. 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.