FDA Approves New Generic Valsartan

On March 12, 2019, FDA announced it had approved a new generic of Diovan (valsartan), a angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure, to lkem Laboratories Limited. The review of the new generic valsartan was prioritized after several valsartan products were recalled because of nitrosamine impurities, which caused a shortage of the medicine.

To ensure this new generic valsartan did not contain nitrosamine impurities, the agency evaluated the company’s manufacturing processes and testing methods to ensure the product does not contain N-Nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (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 stated in a press release.

“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, in the press release. “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.”

Source: FDA